Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1053-2013 — LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physicia

U.S. FDA — Device Enforcement · United States · 2013-02-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1053-2013
Date of alert: 2013-02-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cooper Surgical, Inc.
Product category: device
Product type: Devices

Reported risk: LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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