FDA Device recall Z-1614-2014
Coaxial Micro-Introducer Kit
- FDA Device
- Class II
- terminated
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class II recall of Coaxial Micro-Introducer Kit by Greatbatch Medical, citing greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1614-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-28 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Greatbatch Medical |
| Distribution | US |
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.
Reason
Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
Identifiers
| code_info | W1190519 W1190532 W1190532 W1190514 W1190517 W1190517 W1190516 W1266849 W1266851 W1266850 W1266848 W1298418…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1614-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.