Class 2 Device Recall Coaxial MicroIntroducer Kit

• Date Initiated by Firm: April 28, 2014
• Date Posted: May 13, 2014
• Recall Status: Terminated on May 24, 2016
• Recall Number: Z-1614-2014
• Recall Event ID: 68161
• 510(K)Number: K990705
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Coaxial Micro-Introducer Kit. ; Greatbatch Part Number/Bard Access Systems Order Number/Part Description; ; 10636-001; 8004011; Kit Coax 10 Pack 4FR Bard; ; 10636-002; 8005011; Kit Coax 10 Pack 5FR Bard; ; 10636-007; 8004012; Kit Coax 10 Pack 4FR Bard; ; 10636-008; 8005012; Kit Coax 10 Pack 5FR Bard; ; 10636-009; 8004022; Kit Coax 10 Pack 5FR Bard; ; 10636-010; 8005022; Kit Coax 10 Pack 5FR Bard; ; The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.
• Code Information: W1190519 W1190532 W1190532 W1190514 W1190517 W1190517 W1190516 W1266849 W1266851 W1266850 W1266848 W1298418 W1300005 W1298419 W1298425 W1298426 W1362771 W1362772 W1362773 W1362775 W1383678 W1362774 W1420240 W1420241 W1420242 W1434887 W1434888 W1464513 W1464514 W1464516 W1464511 W1464512 W1464515 W1466090 W1466092 W1466093 W1466091 W1467421 W1477933 W1467420 W1477935 W1477932 W1477934 W1490379 W1477937 W1490378 W1490380 W1490377 W1477936 W1509174 W1509175 W1532502 W1532501 W1509173 W1599234 W1629461 W1661254 W1688745 W1720426 W1746962 W1720428 W1792523 W1786461 W1788967 W1770099 W1807382 W1807383 W1807378 W1872468 W1872469 W1872470 W1927797 W1872468 W1927798 W1927799 W1963380 W2012849 W2012851 W2012850 W2047027 W2058073 W2047028 W2073401 W2047030 W2047031 W2094903 W2110798 W2170053 W2155950 W2170050 W2170052 W2192990 W2211695 W2211696 W2211697 W2268277 W2268271 W2315849 W2315850 W2315845 W2315846 W2315848 W2357893 W2357894 W2371770 W2371771 W2392043 W2357895 W2357896 W2397846 W2371772 W2386295 W2451688 W2451690 W2451691 W2451692 W2451693 W2461057 W2461056 W2461058 W2513845 W2561761 W2561762
• Recalling Firm/ Manufacturer: Greatbatch Medical; 2300 Berkshire Ln N; Minneapolis MN 55441-4575
• For Additional Information Contact: local Greatbatch representative; 763-951-8235
• Manufacturer Reason for Recall: Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
• FDA Determined Cause: Incorrect or no expiration date
• Action: Greatbatch sent an "Urgent Medical Device Recall" letter dated April 25, 2014 to affected customers via email and Fedex. The letter described the Reason for Recall, Risk to Health, and Instructions to Customers. Requested consignees to immediately place affected devices in quarantine and to complete and return the Field Correction Action Response Form. For questions they should contact their local Greatbatch representative or 1-763-951-8235, or e-mail FieldActionCenter@Greatbatch.com.
• Quantity in Commerce: 6,642 sets (66,420 devices)
• Distribution: US Nationwide Distribution in the state of UT.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DYB and Original Applicant = MEDAMICUS, INC.