Drug 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.
D-1650-2012
Product summary
- Event
- Event 62775
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 Trays
- Official record key
drug-enforcement:D-1650-2012
Official wording
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.
Code information: Lot #: 25915-1111, Exp 12/2012
Distribution pattern: GA, MD, MA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility