Recall Z-1614-2014 ยท DYB Introducer, Catheter
Greatbatch Medical
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-Introd
| Date | May 13, 2014 (initiated Apr 28, 2014) |
| Status | Terminated |
| Reason | Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set. |
| Root 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 | 6,642 sets (66,420 devices) |
| Distribution | US Nationwide Distribution in the state of UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990705 | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET Medamicus, Inc., Jun 28, 1999 |