CMS-8934 Custom Phlebectomy Tray — Class II drug recall D-1650-2012
Terminated recall by Custom Medical Specialties, Inc., reported 2012-08-29, distributed in GA, MA, MD. Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which wer
| Recall number | D-1650-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Medical Specialties, Inc., Pine Level, NC, United States |
| Recall initiated | 2012-07-23 |
| Classified | 2012-08-17 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2012-10-11 |
| Distributed | GA, MA, MD |
| Quantity | 20 trays |
| Reason classes | sterility, packaging |
| Lot numbers | 25915-1111 |
| Expiration dates | 2012-12 |
Product
CMS-8934 Custom Phlebectomy 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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1650-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.