Recall Z-2036-2018 ยท KGO Surgeon'S Gloves
WRP Asia Pacific Sdn Bhd
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
| Date | May 7, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | On May 7, 2018, WRP (contract manufacturer) issued an Urgent Medical Device Recall notice to its affected customer. The customer then notified its U.S. consignee, American Health Packaging, which in turn disseminated the recall information to affected consignees, down to the user level. The following instructions were provided to affected customers: If you are a Distributor: 1. Immediately examine your inventory, quarantine and discontinue distribution of these lots. 2. Carry out a physical count and record this data on the Business Reply Card and the Packing slip, which are included with th |
| Quantity | 201,000 pairs |
| Distribution | Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020019 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) Wrp Asia Pacific Sdn. Bhd., Jan 23, 2002 |