FDA Medical Device Recalls (openFDA)
WRP Asia Pacific Sdn Bhd: AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
- Recall number
- Z-2036-2018
- Recalling firm
- WRP Asia Pacific Sdn Bhd
- Product
- AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
- Status
- Terminated
- Initiated
- 2018-05-07
- Posted
- not on file
- Terminated
- 2019-05-30
- 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 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
- 201,000 pairs
- Distribution
- Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.
- Lot, serial or model codes
- Lot 705366565
- 510(k) numbers
- ["K020019"]
- PMA numbers
- not on file
- Product code
- KGO
- Firm FEI
- 3002808507
- Firm city
- Sepang
- Firm state
- not on file
- Firm country
- Malaysia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28