Cook Medical Needles, Peel-Away® Introducers, and Dilators
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected product |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Disposable Chib Biopsy Needles |
More than 10 numbers, contact manufacturer. |
DCHN-18-15.0 |
Peel-Away Introducer Sets And Trays |
More than 10 numbers, contact manufacturer. |
PLVW-XXX |
Coons Dilator-Polyethylene |
More than 10 numbers, contact manufacturer. |
JCD12.0-38-20-COONS |
Vessel Dilator-Polyethylene |
More than 10 numbers, contact manufacturer. |
JCD 8.0-38-20 |
Issue
Cook Medical identified that devices from the affected device lots may have packaging seals that do not meet peel strength specifications. This creates a potential of a sterile barrier failure that could result in compromised device sterility.
Recall start date: March 1, 2024
Additional information
Details
| Cook, Inc. |
| 750 Daniels Way, Bloomington, Indiana, United States, 47404 |
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