FDA Drug recall D-1651-2012
CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialtie…
- FDA Drug
- Class II
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class II recall of CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialtie… by Custom Medical Specialties, citing lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1651-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-23 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Custom Medical Specialties |
| Distribution | GA, MA, MD |
Product
CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product description.
Reason
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Identifiers
| code_info | Lot #: 26124-1112, Exp 12/2012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1651-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.