Curity Staple Remover Kit Recalled Due to Supplier OTC Drug Issue
Covidien is recalling Curity Staple Remover Kits because a supplier recalled OTC drug products used in the kits.
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 a voluntary precautionary action triggered by a supplier recall of OTC drug components, with no reported injuries or illnesses in the source text.
Plain-English summary
On March 26, 2013, Covidien LLC received a recall notice from its supplier, CareFusion. CareFusion is recalling a variety of over-the-counter (OTC) drug products, including the 10% Povidone Iodine SEPP Applicator, which is utilized in specific convenience kits.
As a result, Covidien is recalling the Curity Staple Remover Kit (Product Code: 66701). The affected products were distributed worldwide, including nationwide in the USA and in Panama. A total of 52,363 units were distributed.
Consumers should stop using the recalled kits and contact the manufacturer or supplier for further instructions regarding the specific OTC drug component.
The recalled product
- Product
- Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 52,363
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)
- 103387264
- 117881264
- 110983964
- 214981164
- 117488864
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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