Status
Completed
Drug Enforcement D-0272-2023
Lack of sterility assurance
Classification
Class II
Report Date
February 22, 2023
Termination Date
—
Product Information
- Product description
- 0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Product quantity
- 114 bags total
- Reason for recall
- Lack of sterility assurance
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Dispensed to Patients Nationwide.
Location & Firm
- Recalling firm
- Sentara Infusion Services
- Address
-
535 Independence Pkwy Ste 300, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0272-2023
- Event ID
- 91466
- Recall initiation date
- December 27, 2022
- Center classification date
- February 15, 2023
- Code info
- Beyond Use date December 24 - December 31, 2022
- More code info
- —