Status
Terminated
Drug Enforcement D-627-2013
Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Classification
Class II
Report Date
July 10, 2013
Termination Date
June 18, 2015
Product Information
- Product description
- Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015
- Product quantity
- N/A
- Reason for recall
- Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide & Puerto Rico
Location & Firm
- Recalling firm
- Baxter Healthcare Corp.
- Address
-
1 Baxter Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-627-2013
- Event ID
- 65288
- Recall initiation date
- May 21, 2013
- Center classification date
- June 28, 2013
- Code info
- Lot #: Product code 2B0973: P279935, Exp 7/13
- More code info
- —