Cook Medical Needles, Peel-Away® Introducers, and Dilators
Brand(s)
Last updated
Summary
Product
Cook Medical Needles, Peel-Away® Introducers, and Dilators
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
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 DCHN-22-10.0 DCHN-22-20.0 DCHN-18-10.0 DCHN-22-10.0-U DCHN-22-15.0 DCHN-22-15.0-U |
| 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 JCD14.0-38-20-COONS JCD10.0-38-20-COONS |
| Vessel Dilator-Polyethylene | More than 10 numbers, contact manufacturer. | JCD 8.0-38-20 JCD 8.0-38-15 JCD10.0-38-20 JCD 8.0-38-20-HC JCD20.0-38-20 JCD22.0-38-20 JCD16.0-38-20-HC JCD14.0-38-20-HC |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - General and plastic surgery
Companies
| Cook, Inc. |
| 750 Daniels Way, Bloomington, Indiana, United States, 47404 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75601
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