Home / Recalls / WRP Asia Pacific Sdn Bhd / Z-2036-2018

Z-2036-2018 Class II Terminated

Recalled by WRP Asia Pacific Sdn Bhd — Sepang, N/A

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