CooperSurgical LEEP REDIKIT Recalled for Incorrect Lidocaine Concentration Labeling
CooperSurgical is recalling LEEP REDIKIT surgical kits because the labels list 2% Lidocaine HCl, but the kits contain 1% Lidocaine HCl vials.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 III, which the rubric associates with scores of 1 or 2. The hazard is a minor labeling error regarding drug concentration, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
CooperSurgical, Inc. is recalling 305 units of the LEEP REDIKIT, a surgical preparatory kit used for Loop Electrosurgical Excision Procedures (P/N 6061). The recall is due to a labeling error where the kit is labeled as containing Lidocaine HCl (2%) drug cartridges, but it actually contains vials of Lidocaine HCl (1%).
The affected product is identified by LOT 187889. The kits were distributed in the United States to the states of Alabama, Arizona, California, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Vermont.
Healthcare providers and consumers should stop using the affected kits and contact CooperSurgical, Inc. for further instructions or a return. This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
- Manufacturer
- CooperSurgical, Inc.
- Category
- Medical Device — Surgical Kit
- Hazard
- Affected units
- 305
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 (1)
- LOT 187889
Distribution
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