Recall Z-0621-2011 ยท KGO Surgeon'S Gloves
Ansell Healthcare Products LLC
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
| Date | Dec 15, 2010 (initiated Sep 3, 2010) |
| Status | Terminated |
| Reason | open package seams on sterile gloves |
| 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: inf |
| Quantity | 4000 units |
| Distribution | International distribution only: France and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000295 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Ansell Perry, Feb 16, 2000 |