Z-2036-2018Class II

AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

Name: Z-2036-2018 AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
Creator: WRP Asia Pacific Sdn Bhd
Published: 2018-05-07
License: https://open.fda.gov/license/

WRP Asia Pacific Sdn Bhd / initiated 2018-05-07 / Terminated / root cause: manufacturing process

FDA source

WRP Asia Pacific Sdn Bhd began a recall of AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 on 2018-05-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2036-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-07
Posted: 2018-05-30
Terminated: 2019-05-30
Recalling firm: WRP Asia Pacific Sdn Bhd
Product: AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
Product code: KGO Surgeon'S Gloves
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 201,000 pairs
Distribution: Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.
Product codes and lots: Lot 705366565

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2036-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2036-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30

Product code KGO

K020019Class IPowder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim)Wrp Asia Pacific Sdn. Bhd. / cleared 2002-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)