Cooper Surgical Recalls LEEP RediKit Due to Incorrect Anesthetic Labeling
Cooper Surgical is recalling LEEP RediKit products because the tray lid label incorrectly lists Xylocaine, while the kit actually contains Polocaine.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error regarding the specific anesthetic included, which fits the criteria for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Cooper Surgical, Inc. is recalling 4,395 units of LEEP RediKit Product No. 6060. These kits are used in Loop Electrosurgical Excision Procedures to remove abnormal cervical tissue. The recall is due to a labeling discrepancy regarding the local anesthetics included in the kit.
The tray lid label for the recalled kits lists Xylocaine (Lidocaine) HCL (2%). However, the kits do not contain Xylocaine. Instead, they contain Polocaine (Mepivacaine) HCL (3%), which is not listed on the tray label. The affected lots are 120716, 116657, 116658, and 116659, with expiration dates ranging from May 31, 2013, to August 31, 2013.
The products were distributed nationwide, including Puerto Rico. Healthcare providers and facilities should stop using these kits and contact Cooper Surgical for instructions on how to return the affected products.
The recalled product
- Product
- 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 anaestheti
- Manufacturer
- Cooper Surgical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 4,395
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot 120716
- exp 8-31-13
- Lot 116657 exp. 6-30-13
- Lot 116658 exp. 5-31-13
- Lot 116659 exp. 7-31-13
Distribution
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