Status
Terminated
Drug Enforcement D-183-2013
Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Classification
Class II
Report Date
March 13, 2013
Termination Date
May 15, 2015
Product Information
- Product description
- 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
- Product quantity
- 325,056 bags
- Reason for recall
- Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
- 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-183-2013
- Event ID
- 64001
- Recall initiation date
- January 8, 2013
- Center classification date
- March 7, 2013
- Code info
- Lot Number 02-117-JT Exp. 02/13
- More code info
- —