AmerisourceBergen PF Latex SG recall: Undeclared Allergen
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
Why was AmerisourceBergen PF Latex SG 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 705366565
- Product
- AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
- Recalling firm
- WRP Asia Pacific Sdn Bhd
- Quantity
- 201,000 pairs
- Distribution
- Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.
- Recall date
- June 6, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)