Z-0456-2019 Class II Terminated
FDA device recall Z-0456-2019 was initiated by American Contract Systems, Inc. on Dec 28, 2016 and is designated Class II. Reason for recall: Powdered Surgical Gloves are an FDA banned substance. The recall status is terminated (terminated Nov 14, 2018). Affected quantity: 1,180 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 21, 2018
- Initiation Date
- Dec 28, 2016
- Termination Date
- Nov 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,180 kits
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.
Distribution Pattern
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0456-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026