Status
Terminated
Drug Enforcement D-184-2013
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Classification
Class II
Report Date
March 13, 2013
Termination Date
March 31, 2015
Product Information
- Product description
- HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
- Product quantity
- 11,412 bags
- Reason for recall
- Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-184-2013
- Event ID
- 63522
- Recall initiation date
- October 22, 2012
- Center classification date
- March 5, 2013
- Code info
- Lot # 10-199-JT Exp. 10/13
- More code info
- —