Recall Z-1234-2017 ยท FCH Tray, Biopsy, Without Biopsy Instruments
Custom Medical Specialties, Inc.
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
| Date | Sep 20, 2016 |
| Status | Open, Classified |
| Reason | Sterility of syringe product could not be assured. |
| Root cause | Nonconforming Material/Component |
| Action | A letter was issued to customers on 9/20/2016 notifying them of the recall of the 10 cc syringe by BD. The letter tells them not to use the syringe in the kit, and to use the syringe on the outside of the kit which is not part of the recall. |
| Quantity | 80 syringes |
| Distribution | US Distribution to ID and OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.