Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. ...
FDA Recall #Z-0456-2019 — Class II — December 28, 2016
Product Description
Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.
Reason for Recall
Powdered Surgical Gloves are an FDA banned substance.
Recalling Firm
American Contract Systems, Inc. — Kansas City, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,180 kits
Distribution
US Distribution to states of: IL, MO, NE, and OH.
Code Information
Tray Number (Powdered Glove code): MHCE23D (ANS5711104), MHAP41D (ANS7825), MHOC43C (ANS7825), MHPO42D (ANS7825), GVTH071 (ANS5711104), GVTK05L (ANS5711104), GVTK05M (ANS5711104), CXTR68D (ANS5711105), MDEY35H (BAX2D7202I), MDEY35I (BAX2D7202I), FHLV24 (ANS5711105, ANS5711101), LKCA02A (ANS5710503), WIDE32 (ANS7824), UTLU70F (ANS7825), FIOH02H (BAX2D7254)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated