URGENT Field Safety Notice



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Transcription:

COMMERCIAL NAME OF AFFECTED PRODUCTS: TYPE OF ACTION: TELEFLEX REFERENCE: URGENT Field Safety Notice Arrow International Inc. ( Arrow ) c/o Teleflex, IDA Business & Technology Park Dublin Road, Athlone Co. Westmeath, Ireland 15 May 2014 - Pressure Injectable Central Venous Catheter Product - Multiple-Lumen Central Venous Catheterization Product - Multiple-Lumen Central Venous Catheterization Product with ARROWg+ard Antimicrobial Surface Advisory Notice 4004492 PART NUMBERS Ref Appendix 1 Dear Customer, Arrow International, Inc. ( Arrow ) is notifying customers that there is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on central venous catheters (CVCs). As an example, the distal lumen may be printed with the word medial 18 GA instead of distal 16GA. The misprint does not impact the use of the product including use of individual lumens for infusion, blood draws, etc. The colour coding of all hubs is correct and corresponds to the Arrow system: White = Proximal Lumen; Grey = Medial Lumen 1; Blue = Medial Lumen 2; Brown = Distal Lumen. For Pressure Injectable Catheters the colour coding and printing on the winged hubs, as indicated in Figure 1, is correct and indicates the lumen to be used for pressure injection. NO CT is correctly printed as a warning on the non-pressure injectable hubs. Institutional policies and procedures and manufacturer instructions should be followed for pressure injection and use of the catheters as well as for non-pressure injectable catheter applications. Figure 1: Pressure Injectable Catheters Figure 2: Non - Pressure injectable catheters Page 1 of 2

1. ADVISORY NOTICE CORRECTIVE ACTION INSTRUCTIONS: Advice on action to be taken by Healthcare Institution and Medical Staff Please provide this Advisory Notice to all those who need to be aware of it within your organisation. Please consider, clinicians, risk managers, supply chain/distribution centres, etc. in the circulation of this notice. There is no further action required. 2. Contact reference person Should you require any further information or support concerning this issue, please contact: Customer Service: Contact: Hélène Sauvage Telephone: +44 (0)1494 532761 FAX: +44 (0)1494 524650 E-mail: orders.uk@teleflex.com Arrow is committed to providing high quality, safe and effective products. apologize for any inconvenience this action may cause your operations. We sincerely If you have further questions please feel free to contact our customer service or sales representatives. For and on behalf of Arrow: VP QARA, International Page 2 of 2

AD-14854 CVC KIT: 4-LUMEN 8.5FR X 30CM ASK-14854-KR CVC KIT: 4-LUMEN 8.5 FR X 12" (30 CM) AD-24854 CVC KIT: 4-LUMEN 8.5FR X 30CM ASK-14854-KRX CVC KIT: 4-LUMEN 8.5 FR X 12" (30 CM) AD-24854-NL CVC SET: 4-LUMEN 8.5FR X 30CM ASK-15854-CH CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) AG-15854-E CVC SET: 4-LUMEN 8.5FR X 20CM ASK-15854-FAM CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) AG-15854-UN CVC SET: 4-LUMEN 8.5FR X 20CM ASK-15854-KR CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) AG-25854-E CVC SET: 4-LUMEN 8.5FR X 20CM ASK-15854-KR(5) CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) AH-12854 CVC KIT: 4-LUMEN 8.5FR X 16CM ASK-15854-KRX CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) AH-12854-L CVC KIT: 4-LUMEN 8.5FR X 16CM ASK-22854-IM MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) AK-15854-LA CVC KIT: 4-LUMEN 8.5FR X 20CM ASK-24854-PH CVC KIT: 4-LUMEN 8.5 FR X 12" (30 CM) AK-22854 MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-24854-PH1 CVC KIT: 4-LUMEN 8.5 FR X 12" (30 CM) AK-22854-SK CVC KIT: 4-LUMEN 8.5 FR X 16 CM ASK-24854-PH1X CVC KIT: 4-LUMEN 8.5 FR X 12" (30 CM) AK-24854 CVC KIT: 4-LUMEN 8.5 FR X 30 CM ASK-25854-CH QUAD-LUMEN CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) AK-25854 CVC KIT: 4-LUMEN 8.5 FR X 20 CM ASK-25854-ELM CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) AK-25854-SK CVC KIT: 4-LUMEN 8.5 FR X 20 CM ASK-25854-MCO CVC KIT: 4-LUMEN 8.5 FR X 20 CM AK-42854-CDC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-25854-NC CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) AK-42854-P1A PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+ ASK-25854-UPM CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) AK-42854-SK CVC KIT: 4-LUMEN 8.5 FR X 16 CM ASK-25854-WF CVC KIT: 4-LUMEN 8 FR X 8" (20 CM) AK-45854-CDC CVC KIT: 4-LUMEN 8.5 FR X 20 CM ASK-42854-AH MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) AK-45854-P1A PI CVC KIT: 4-L 8.5 FR X 20 CM AGB+ ASK-42854-AKP1A PI CVC KIT: 4-L 8.5 FR X 6" AK-45854-SK CVC KIT: 4-LUMEN 8.5 FR X 20 CM ASK-42854-BW CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ARCS-22854-E CVC SET: 4-LUMEN 8.5FR X 16CM ASK-42854-CMC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ARCS-25854-E CVC SET: 4-LUMEN 8.5FR X 20CM ASK-42854-CMC1 MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ARCS-42854-E CVC SET: 4-LUMEN 8.5FR X 16CM ASK-42854-CMC2 MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ARCV-20854 CVC SET: 4-LUMEN 8.5FR X 11CM ASK-42854-CSM CVC SET: 4-LUMEN 8.5 FR X 6" (16 CM) ARCV-22854 CVC SET: 4-LUMEN 8.5FR X 16CM ASK-42854-FAH MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ARCV-25854 CVC SET: 4-LUMEN 8.5FR X 20CM ASK-42854-JM MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ARCV-42854 CVC SET: 4-LUMEN 8.5FR X 16CM ASK-42854-JMX MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) Page 1 of 6

ASK-42854-KFSH PI CVC KIT: 4-L 8.5 FR X 6" (16 CM) AGB+ ASK-42854-PNMX PI CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-42854-LLU CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-42854-PRR PI CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-42854-MMC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-42854-PSAC QUAD-LUMEN PI CVC KIT: 4-L 8.5 FR X 6A' (16 CM) ASK-42854-MSK MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-42854-PSH MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-42854-NMM MULTI-LUMEN CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-42854-PSHC PI CVC KIT: 3-L 7 FR X 6" (16 CM) AGB+ ASK-42854-OHSU CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-42854-PSHCX1 PI CVC KIT: 3-L 7 FR X 6" (16 CM) AGB+ ASK-42854-OHSUX CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-42854-PSHCX2 PI CVC KIT: 3-L 7 FR X 6" (16 CM) AGB+ ASK-42854-OU MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-42854-PTG PI CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-42854-PBW PI CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-42854-PTG1 PI CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-42854-PBW(5) PI CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-42854-PUCI PI CVC KIT: 4-L 8.5 FR X 16 CM ASK-42854-PBW1 MULTI-LUMEN PI CVC KIT: 4-L 7 FR X 6" (16 CM) ASK-42854-PUPM PI CVC KIT: 4-L 8.5 FR X 16 CM ASK-42854-PBW4 PI CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-42854-RR MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-42854-PCMC PI CATHETER 4-L W/ACCESSORY: 8.5FR X 16CM AGB+ ASK-42854-SH MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-42854-PH MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-45854-AKP1A MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-42854-PHSD MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-45854-BMC CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-42854-PMC PI CVC KIT: 4-L 8.5 FR X 16 CM AGB ASK-45854-CH MULTI-LUMEN CVC KIT: 3-L 7 FR X 6" (20 CM) ASK-42854-PMC-S PI CVC KIT: 4-L 8.5 FR X 6" (16 CM) AGB+ ASK-45854-CMM CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-42854-PMGH MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-45854-CMM1 CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-42854-PMGH1 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 6" ASK-45854-ECL MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-42854-PMGHX MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-45854-ECL1 MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-42854-PMSK MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-45854-ECLH MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-42854-PMW MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 6" ASK-45854-FHC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-42854-PNH PI CVC KIT: 4-L 8.5 FR X 6" (16 CM) AGB+ ASK-45854-JM MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-42854-PNM PI CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-45854-JM(8) MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-42854-PNM1 PI CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-45854-JMX MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-42854-PNMM PI MULTI-LUMEN CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-45854-JPS MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-42854-PNMMX PI MULTI-LUMEN CVC KIT: 4-LUMEN 8.5 FR X 6" (16 CM) ASK-45854-LDS MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) Page 2 of 6

ASK-45854-MH CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-45854-PJPS1 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-MMC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PLGH MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" ASK-45854-MMCP MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PMB PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) AGB+ ASK-45854-MMH CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-45854-PMC PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) AGB+ ASK-45854-NCH MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PMCG PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) AGB+ ASK-45854-NG CVC KIT: 4-L 8.5 FR X 8" (20 CM) AGB+ ASK-45854-PMC-S PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) AGB+ ASK-45854-NGX CVC KIT: 4-L 8.5 FR X 8" (20 CM) AGB+ ASK-45854-POSF MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PAGH MULTI-LUMEN PI CVC KIT: 4-LUMEN 8.5 FR X 8" (20CM) ASK-45854-PPCM MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PBMC PI CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-45854-PPCMX MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PCCH MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PPH MULTI LUMEN PI CVC KIT: 4-LUMEN 8.5 FR X 12" (30 CM) ASK-45854-PCCH1 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PPHC MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PCH PI CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-45854-PPHR MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PCHS1 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PPHR1 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PCHS1(3) MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PPM MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PCIR PI CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-45854-PPP PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) AGB+ ASK-45854-PCMH MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PPR MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PCMH1 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PSCR MULTI-LUMEN PI CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-45854-PCOR QUAD-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PSFH MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PDCH MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PSFM PI CVC KIT: 4-LUMEN 8.5 FR X 20 CM ASK-45854-PECL MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PSFMX PI CVC KIT: 4-LUMEN 8.5 FR X 20 CM ASK-45854-PFAM CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-45854-PSHS PI CVC KIT: 4-L 8.5 FR X 20 CM AGB ASK-45854-PFHC MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PSJH MULTI-LUMEN PI CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-45854-PGM MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PSJM PI CVC KIT: 4-L 8.5 FR X 20 CM AGB ASK-45854-PGM1 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" ASK-45854-PSLU MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PH MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PST MULTI-LUMEN CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) ASK-45854-PHMT PI CVC KIT: 4-L 8.5 FR X 20 CM AGB ASK-45854-PSV MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PJPS MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-PUC PI CVC KIT: 4-L 8.5 FR X 20 CM AGB Page 3 of 6

ASK-45854-PUCI PI CVC KIT: 4-L 8.5 FR X 20 CM AGB CA-45854-P1A PI CVC KIT: 4-L 8.5 FR X 20 CM AGB+ ASK-45854-PUIC PI CVC KIT: 4-L 8.5 FR X 20 CM AGB CDA-42854-P1A PI CVC KIT: 4-L 8.5 FR X 16 CM AGB ASK-45854-PUOL MULTI-LUMEN PI CVC KIT: 4-LUMEN 8.5 FR X 20 CM CDA-45854-P1A PI CVC KIT: 4-L 8.5 FR X 20 CM AGB ASK-45854-PUP PI CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) CDC-24854-X1A CVC KIT: 4-L 8.5 FR X 30 CM ANTIMICROBIAL ASK-45854-PUPM MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) CDC-42854-1A 4-L CVC KIT: 8.5 FR X 16 CM ASK-45854-PUR MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) CDC-42854-1A-X MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 6" (16 CM) ASK-45854-PUR1 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" CDC-42854-P1A PI CVC KIT: 4-L 8.5 FR X 16 CM AGB ASK-45854-PUSC MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) CDC-42854-XP1A PI CVC KIT: 4-L 8.5 FR X 16 CM AGB ASK-45854-PVA MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) CDC-45854-1A 4-L CVC KIT: 8.5 FR X 20 CM ASK-45854-QMC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) CDC-45854-1A-X MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-RYM MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) CDC-45854-P1A MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" (20 CM) ASK-45854-ST MULTI-LUMEN CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) CDC-45854-XP1A PI CVC KIT: 4-L 8.5 FR X 20 CM AGB ASK-45854-UAB MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) CH-45854-H CVC KIT: 4-LUMEN 8.5FR X 20CM ASK-45854-UIC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) CK-15854-E CVC KIT: 4-LUMEN 8.5FR X 20CM ASK-45854-USC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 8" (20 CM) CS-12854-E CVC SET: 4-LUMEN 8.5FR X 16CM ASK-45854-UTMC CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) CS-14854-E CVC SET: 4-LUMEN 8.5 FR X 30 CM AT-25854-E CVC KIT: 4-LUMEN 8.5FR X 20CM CS-15854-E CVC SET: 4-LUMEN 8.5 FR X 20 CM BE-S25854-SEL MULTI-LUMEN/PSI KIT CS-22854-E CVC SET: 4-LUMEN 8.5 FR X 16 CM BO-25854 CVC SET: 4-LUMEN 8.5FR X 20CM CS-25854-E CVC SET: 4-LUMEN 8.5 FR X 20 CM BR-10854 CVC SET: 4-LUMEN 8.5FR X 11CM CS-42854-E CVC SET: 4-LUMEN 8.5 FR X 16 CM BR-12854 CVC SET: 4-LUMEN 8.5FR X 16CM CS-42854-HP CVC KIT: 4-LUMEN 8.5FR X 16CM BR-15854 CVC SET: 4-LUMEN 8.5FR X 20CM CS-45854-E CVC SET: 4-LUMEN 8.5 FR X 20 CM BR-20854 CVC SET: 4-LUMEN 8.5FR X 11CM CS-45854-HP CVC KIT: 4-LUMEN 8.5FR X 20CM BR-22854 CVC SET: 4-LUMEN 8.5FR X 16CM CV-10854 CVC SET: 4-LUMEN 8.5FR X 11CM BR-25854 CVC SET: 4-LUMEN 8.5FR X 20CM CV-12854 CVC SET: 4-LUMEN 8.5FR X 16CM BWH-42854-1 CVC KIT: 4-LUMEN 8.5 FR X 16 CM CV-15854 CVC SET: 4-LUMEN 8.5FR X 20CM CA-42854-P1A PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+ CV-20854 CVC SET: 4-LUMEN 8.5FR X 11CM Page 4 of 6

CV-22854 CVC SET: 4-LUMEN 8.5FR X 16CM DE-25854-UKSH CVC SET: 4-LUMEN 8.5FR X 20CM CV-22854-QE CVC SET: 4-LUMEN 8.5FR X 16CM DE-S15854-BV MULTI-LUMEN/PSI KIT CV-22854-SR CVC SET: 4-LUMEN 8.5FR X 16CM DE-S22854-LMU MULTI-LUMEN/PSI KIT CV-25854 CVC SET: 4-LUMEN 8.5FR X 20CM DO-14854 CVC KIT: 4-LUMEN 8.5 FR X 30 CM CV-25854-LJ CVC SET: 4-LUMEN 8.5FR X 20CM ES-14854-D CVC SET: 4-LUMEN 8.5FR X 30CM CV-42854 CVC SET: 4-LUMEN 8.5 FR X 16 CM EU-12854-N CVC SET: 4-LUMEN 8.5FR X 16CM CV-45854 CVC SET: 4-LUMEN 8.5 FR X 20 CM EU-14854-CVT CVC SET: 4-LUMEN 8.5FR X 30CM DA-15854 CVC KIT: 4-LUMEN 8.5FR X 20CM EU-14854-EN CVC SET: 4-LUMEN 8.5FR X 30CM DE-12854-BBT CVC KIT: 4-LUMEN 8.5FR X 16CM EU-15854-CVET CVC SET: 4-LUMEN 8.5FR X 20CM DE-12854-S CVC SET: 4-LUMEN 8.5FR X 16CM EU-15854-CVT CVC SET: 4-LUMEN 8.5FR X 20CM DE-12854-UKSH CVC SET: 4-LUMEN 8.5FR X 16CM EU-15854-CVTS CVC SET: 4-LUMEN 8.5FR X 20CM DE-14854-S CVC SET: 4-LUMEN 8.5FR X 30CM EU-15854-EN CVC SET: 4-LUMEN 8.5FR X 20CM DE-14854-UW CVC KIT:4-LUMEN 8.5FR X 30CM EU-25854-CVT CVC SET: 4-LUMEN 8.5FR X 20CM DE-15854-CB CVC SET: 4-LUMEN 8.5FR X 20CM EU-25854-EN CVC SET: 4-LUMEN 8.5FR X 20CM DE-15854-HZO CVC KIT: 4-LUMEN 8.5FR X 20CM EU-25854-IMIN CVC KIT: 4-LUMEN 8.5FR X 20CM DE-15854-KKR CVC KIT: 4-LUMEN 8,5FR X 20CM EU-42854-CVCPS CVC KIT: 4-LUMEN 8.5FR X 16CM DE-15854-S CVC SET: 4-LUMEN 8.5FR X 20CM EU-45854-CVCPS CVC KIT: 4-LUMEN 8.5FR X 20CM DE-15854-UKSH CVC SET: 4-LUMEN 8.5FR X 20CM EU-45854-MSB CVC KIT: 4-LUMEN 8.5FR X 20CM DE-22854-BB CVC KIT: 4-LUMEN 8.5FR X 16CM FR-42854-IP CVC KIT: 4-LUMEN 8.5FR X 16CM DE-24854-KGU CVC KIT: 4-LUMEN 8.5FR X 30CM FR-45854-IP CVC KIT: 4-LUMEN 8.5FR X 20CM DE-24854-KN CVC KIT: 4-LUMEN 8.5FR X 30CM GU-24854 CVC KIT: 4-LUMEN 8.5FR X 30CM DE-24854-ZW CVC KIT:4-LUMEN 8,5FR X 30CM HN-12854 CVC KIT: 4-LUMEN 8.5FR X 16CM DE-25854-BB CVC KIT: 4-LUMEN 8.5FR X 20CM IB-45854-GUQ CVC KIT: 4-LUMEN 8.5FR X 20CM DE-25854-KGU CVC KIT: 4-LUMEN 8.5FR X 20CM ICU-15854 CVC KIT: 4-LUMEN 8.5FR X 20CM DE-25854-OUF CVC KIT: 4-LUMEN 8.5FR X 20CM IT-45854-GR CVC KIT: 4-LUMEN 8.5FR X 20CM DE-25854-S CVC SET: 4-LUMEN 8.5FR X 20CM JM-25854 CVC KIT: 4-LUMEN 8.5 FR X 20 CM DE-25854-UBB CVC KIT: 4-LUMEN 8,5FR X 20CM KW-15854 CVC KIT: 4-LUMEN 8.5 FR X 20 CM Page 5 of 6

LA-14854 CVC KIT: 4-LUMEN 8.5FR X 30CM SL-25854 CVC KIT: 4-LUMEN 8.5FR X 20CM MM-24854 CVC KIT: 4-LUMEN 8.5 FR X 30 CM STF-45854-1 CVC KIT: 4-LUMEN 8.5 FR X 20 CM MM-25854-SP CVC KIT: 4-LUMEN 8.5 FR X 20 CM TI-42854-MSB CVC KIT: 4-LUMEN 8.5FR X 16CM MS-24854-EK CVC KIT: 4-LUMEN 8.5FR X 30CM UE-25854-FS CVC KIT: 4-LUMEN 8.5FR X 20CM MSO-45854-CC CVC KIT: 4-LUMEN 8.5 FR X 20 CM UF-24854 CVC KIT: 4-LUMEN 8.5FR X 30CM MTO-22854-RR CVC KIT: 4-LUMEN 8.5 FR X 16 CM UF-25854 CVC KIT: 4-LUMEN 8.5FR X 20CM MTO-24854-PH CVC KIT: 4-LUMEN 8.5 FR X 30 CM UW-24854-EK CVC KIT: 4-LUMEN 8.5FR X 30CM MTO-25854-BMC CVC KIT: 4-LUMEN 8.5 FR X 20 CM MTO-42854-MMC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 16 CM MTO-45854-BMC CVC KIT: 4-LUMEN 8.5 FR X 8" (20 CM) MTO-45854-MMC MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 20 CM MTO-45854-STF CVC KIT: 4-LUMEN 8.5 FR X 20 CM NL-15854-MCZ CVC KIT: 4-LUMEN 8.5FR X 20CM NL-42854-ASZ CVC KIT: 4-LUMEN 8.5FR X 16CM NM-25854 CVC KIT: 4-LUMEN 8.5FR X 20CM NR-25854 CVC KIT: 4-LUMEN 8.5 FR X 20 CM OF-25854 CVC KIT: 4-LUMEN 8.5FR X 20CM OW-14854-E CVC KIT: 4-LUMEN 8.5FR X 30CM RH-42854-1 CVC KIT: 4-LUMEN 8.5 FR X 16 CM RR-22854 CVC KIT: 4-LUMEN 8.5 FR X 16 CM SA-09854 MULTI-LUMEN/PSI KIT SA-12854 CVC SET: 4-LUMEN 8.5FR X 16CM SA-15854 CVC SET: 4-LUMEN 8.5FR X 20CM SA-22854-EU CVC SET: 4-LUMEN 8.5FR X 16CM SA-25854-EU CVC SET: 4-LUMEN 8.5FR X 20CM SE-15854-L MULTI-LUMEN/PSI KIT SE-25854-L CVC KIT: 4-LUMEN 8.5FR X 20CM Page 6 of 6