AmerisourceBergen PF Latex SG recalled over undeclared allergens

Recall date

May 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

WRP Asia Pacific Sdn Bhd recalls AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

Recall number

Z-2036-2018

FDA classification

Class II

Brand / firm

WRP Asia Pacific Sdn Bhd

Sold / distributed

Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112