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
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.
Lot numbers, UPCs & expiration codes
Lot #: 25744-1111, Exp 09/2012
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-1649-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 23, 2012
- FDA report date
- Aug 29, 2012
- Quantity
- 35 Trays
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Custom Medical Specialties, Inc.
Original FDA data
Every field from FDA enforcement report D-1649-2012, 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 #: 25744-1111, Exp 09/2012
- Postal code
- 27568
- Report date
- Aug 29, 2012
- Product type
- Drugs
- Recall number
- D-1649-2012
- Classification
- Class II
- Recalling firm
- Custom Medical Specialties, Inc.
- Product quantity
- 35 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
- 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.
- Distribution pattern
- GA, MD, MA
- Recall initiation date
- Jul 23, 2012
- Initial firm notification
- FAX
- Center classification date
- Aug 17, 2012