Status
Terminated
Drug Enforcement D-1649-2012
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
Classification
Class II
Report Date
August 29, 2012
Termination Date
October 11, 2012
Product Information
- Product description
- Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
- Product quantity
- 35 Trays
- 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
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- GA, MD, MA
Location & Firm
- Recalling firm
- Custom Medical Specialties, Inc.
- Address
-
330 East Main Street, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1649-2012
- Event ID
- 62775
- Recall initiation date
- July 23, 2012
- Center classification date
- August 17, 2012
- Code info
- Lot #: 25744-1111, Exp 09/2012
- More code info
- —