Device product
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.
Z-0392-2014
Product summary
- Event
- Event 66389
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38,400 units
- Official record key
device-enforcement:Z-0392-2014
Official wording
Reason: Incomplete foil seal on one lot of sterile product.
Code information: Lot Number GR13G23028
Distribution pattern: Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.
Derived failure modes
-
Unknown
Incomplete foil seal on one lot of sterile product.