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.
Reported: December 4, 2013 Initiated: September 25, 2013 #Z-0392-2014
Product Description
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.
Reason for Recall
Incomplete foil seal on one lot of sterile product.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 38,400 units
- Distribution
- Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corp.. Units affected: 38,400 units.
Why was this product recalled? ▼
Incomplete foil seal on one lot of sterile product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2013. Severity: Moderate. Recall number: Z-0392-2014.
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