FDA-Device2013-12-04Class II

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.

Baxter Healthcare Corp.
Hazard

Incomplete foil seal on one lot of sterile product.

Sold states
Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.
Affected count
38,400 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0392-2014

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