FDA Device recall Z-1234-2017
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, I…
- FDA Device
- Class II
- ongoing
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class II recall of CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, I… by Custom Medical Specialties, citing sterility of syringe product could not be assured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1234-2017 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2016-09-20 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Custom Medical Specialties |
| Distribution | ID, OR |
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.
Reason
Sterility of syringe product could not be assured.
Identifiers
| code_info | Lots 40629-1609 an 40631-1609 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1234-2017%22
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