Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 26124-1112, Exp 12/2012
Where it was sold
GA, MD, MA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1651-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 23, 2012
- FDA report date
- Aug 29, 2012
- Quantity
- 25 Trays
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Custom Medical Specialties, Inc.
Original FDA data
Every field from FDA enforcement report D-1651-2012, exactly as published.
Show all FDA fields
- City
- Pine Level
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 62775
- Address
- 330 East Main Street
- Code information
- Lot #: 26124-1112, Exp 12/2012
- Postal code
- 27568
- Report date
- Aug 29, 2012
- Product type
- Drugs
- Recall number
- D-1651-2012
- Classification
- Class II
- Recalling firm
- Custom Medical Specialties, Inc.
- Product quantity
- 25 Trays
- Termination date
- Oct 11, 2012
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- GA, MD, MA
- Recall initiation date
- Jul 23, 2012
- Initial firm notification
- FAX
- Center classification date
- Aug 17, 2012