Class 2 Device Recall AmerisourceBergen Sterile Latex Surgical Gloves, Powder Free

• Date Initiated by Firm: May 07, 2018
• Create Date: May 30, 2018
• Recall Status: Terminated on May 30, 2019
• Recall Number: Z-2036-2018
• Recall Event ID: 79992
• 510(K)Number: K020019
• Product Classification: Surgeon's gloves - Product Code KGO
• Product: AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
• Code Information: Lot 705366565
• Recalling Firm/ Manufacturer: WRP Asia Pacific Sdn Bhd; Lot 1, Perusahaan Bandar Baru; Jalan 3; Sepang Malaysia
• For Additional Information Contact: GENCO Pharmaceutical Services; 877-3198964
• Manufacturer 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.
• FDA Determined 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 this letter. Complete the enclosed Business Reply Card even if you do not have any product on hand. 3. Please pass this Recall Notice on ONLY to users that received these product lots. 4. Return the recalled product and the Packing Slip using the prepaid FedEx shipping labels to: GENCO Pharmaceutical Services a subsidiary of FedEx Supply Chain 6101 North 64th Street Milwaukee, WI 53218 If you are a User: 1. Immediately examine your inventory, quarantine and discontinue distribution of these lots. 2. If you have units of the affected products/lots in inventory, please contact GENCO Pharmaceutical Services at 877-319-8964 to receive a recall return packet. If you have not received this product you do not need to request a return packet. 3. Carry out a physical count and record this data on the Business Reply Card and the Packing slip, which are included with this letter. 4. You do not need to contact any patients. 5. Return the recalled product and the Packing Slip using the prepaid FedEx shipping labels to: GENCO Pharmaceutical Services a subsidiary of FedEx Supply Chain 6101 North 64th Street Milwaukee, WI 53218 To receive credit, the reply form and recalled product must be returned to GENCO by August 16th, 2018. For questions about the recall process, call GENCO Pharmaceutical Services at (877) 319-8964.
• Quantity in Commerce: 201,000 pairs
• Distribution: Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KGO