Z-0621-2011

ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell...

Name: Z-0621-2011 ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell...
Creator: Ansell Healthcare Products LLC
Published: 2010-09-03
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2010-09-03 / Terminated / root cause: packaging

FDA source

Ansell Healthcare Products LLC began a recall of ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK... on 2010-09-03. The reason FDA records is "open package seams on sterile gloves". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0621-2011
Status: Terminated
Initiated: 2010-09-03
Posted: 2010-12-15
Terminated: 2011-11-28
Recalling firm: Ansell Healthcare Products LLC
Product: ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri Lanka Intended use: Surgical Gloves
Product code: KGO Surgeon'S Gloves
Reason for recall: open package seams on sterile gloves
Root cause tag: packaging
FDA root cause: Other
Action: The firm, Ansell, sent a letter dated September 3, 2010 to all customers. The letter described the product, problem and actions taken. An Ansell representatives will contact the customer to remove the gloves bearing the noted lot number from their facility; Ansell will ensure that the gloves removed will be replaced shortly with products from a different manufacturing batch and the recall was extended to the retail (hospital and clinic) level requesting that the product be returned. If you have any questions, contact US (334) 615-2563, international telephone 01.34.24.52.52 and email: [email protected].
Quantity in commerce: 4000 units
Distribution: International distribution only: France and Germany
Product codes and lots: Lot 1003006005

Product code KGO

K000295Class IEncore Microptic Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less)Ansell Perry / cleared 2000-02-16

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)