Sepang, N/A, Malaysia
WRP Asia Pacific Sdn Bhd recalls
1 recall recorded since 2018, most recently on 7 May 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 May 2018
- Terminated
- 30 May 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2036-2018
- AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.