Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011
FDA device recall Z-1614-2014 · posted 2014-05-13 · Terminated
Recall details
- Recalling firm
- Greatbatch Medical
- 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.
- Action taken
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 6,642 sets (66,420 devices)
- Distribution
- US Nationwide Distribution in the state of UT.
- Date initiated
- 2014-04-28
- Date posted
- 2014-05-13
- Date terminated
- 2016-05-24
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET (K990705) | Medamicus, Inc. | 1999-06-28 |