Z-2036-2018 Class II Terminated
FDA device recall Z-2036-2018 was initiated by WRP Asia Pacific Sdn Bhd on May 7, 2018 and is designated Class II. Reason for recall: Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitizatio… The recall status is terminated (terminated May 30, 2019). Affected quantity: 201,000 pairs.
Recall Details
- Product Type
- Devices
- Report Date
- June 6, 2018
- Initiation Date
- May 7, 2018
- Termination Date
- May 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 201,000 pairs
Product Description
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
Reason for Recall
Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.
Distribution Pattern
Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.
Code Information
Lot 705366565