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WRP Asia Pacific Sdn Bhd recalls AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
Recalled June 6, 2018 · FDA recall Z-2036-2018 · WRP Asia Pacific Sdn Bhd
Hazard
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. · FDA Class II
Units
201,000 pairs
Sold at
Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.
Description
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.
Product
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
Manufacturer(s)
WRP Asia Pacific Sdn Bhd
Made in
Malaysia
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →