Cook Inc. Recalls Check-Flo Performer Introducers Due to Sheath Length Defect
Cook Inc. is recalling 24 units of Check-Flo Performer Introducers because they were manufactured with sheaths longer than specified.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'High' severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 24 units of Check-Flo Performer Introducers, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571. The recall is due to a manufacturing defect where the products were produced with sheaths that are longer than the specified dimensions.
The affected products, identified by lot number 8858425, were distributed to healthcare facilities in California, Connecticut, Georgia, Massachusetts, New York, Pennsylvania, Virginia, and Wisconsin. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and consumers should stop using the affected devices immediately. Users should contact Cook Inc. for instructions on how to return the products for a refund or replacement.
The recalled product
- Product
- Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Introducer
- Hazard
- Affected units
- 24
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 8858425
Distribution
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