Device product
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
Z-1234-2017
Product summary
- Event
- Event 76276
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80 syringes
- Official record key
device-enforcement:Z-1234-2017
Official wording
Reason: Sterility of syringe product could not be assured.
Code information: Lots 40629-1609 an 40631-1609
Distribution pattern: US Distribution to ID and OR.
Derived failure modes
-
Unknown
Sterility of syringe product could not be assured.