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Terminated

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

FDA Recall Z-0621-2011 · Posted 2010-12-15

Recalling FirmAnsell Healthcare Products LLC
Recall StatusTerminated
Product CodeKGO
Date Initiated2010-09-03
Date Terminated2011-11-28
Product Quantity4000 units

Reason for Recall

open package seams on sterile gloves

Firm 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].

Root Cause

Other

Distribution Pattern

International distribution only: France and Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000295ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)Ansell Perry · 2000-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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