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
This recall has been terminated (originally issued December 15, 2010).
- Company
- Ansell Healthcare Products Llc
- Recall Initiated
- September 3, 2010
- Posted
- December 15, 2010
- Terminated
- November 28, 2011
- Recall Number
- Z-0621-2011
- Quantity
- 4000 units
- Firm Location
- Dothan, AL
- Official Source
- View on FDA website ↗
Reason for Recall
open package seams on sterile gloves
Distribution
International distribution only: France and Germany
Lot / Code Info
Lot 1003006005
Root Cause
Other
Action Taken
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: infofrance@eu.ansell.com.