FDA recall Z-2036-2018

Product

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

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

Key facts

Status

Terminated

Initiation date

2018-05-07

Report date

2018-06-06

Termination date

2019-05-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sepang, N/A, Malaysia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2036-2018