Cook Medical recall in Canada: Medical devices may have compromised sterility
In plain language
This recall involves Cook Medical Needles, Peel-Away® Introducers, and Dilators sold in Canada. They are being recalled because their packaging seals may not meet specifications, which could compromise the sterility of the devices. Healthcare professionals should contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Contact the manufacturer for additional information.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
Disposable Chib Biopsy Needles
Model: DCHN-18-10.0, DCHN-18-15.0, DCHN-22-10.0, DCHN-22-10.0-U, DCHN-22-15.0, DCHN-22-15.0-U, DCHN-22-20.0
Lot: More than 10 numbers, contact manufacturer.
Peel-Away Introducer Sets And Trays
Model: PLVW-XXX
Lot: More than 10 numbers, contact manufacturer.
Coons Dilator-Polyethylene
Model: JCD10.0-38-20-COONS, JCD12.0-38-20-COONS, JCD14.0-38-20-COONS
Lot: More than 10 numbers, contact manufacturer.
Vessel Dilator-Polyethylene
Model: JCD 8.0-38-15, JCD 8.0-38-20, JCD 8.0-38-20-HC, JCD10.0-38-20, JCD14.0-38-20-HC, JCD16.0-38-20-HC, JCD20.0-38-20, JCD22.0-38-20
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Compromised sterility due to packaging defect
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: DCHN-18-10.0, DCHN-18-15.0, DCHN-22-10.0, DCHN-22-10.0-U, DCHN-22-15.0, DCHN-22-15.0-U, DCHN-22-20.0, JCD 8.0-38-15, JCD 8.0-38-20, JCD 8.0-38-20-HC, JCD10.0-38-20, JCD10.0-38-20-COONS, JCD12.0-38-20-COONS, JCD14.0-38-20-COONS, JCD14.0-38-20-HC, JCD16.0-38-20-HC, JCD20.0-38-20, JCD22.0-38-20, PLVW-XXX
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Compromised sterility due to packaging defect
What should consumers do?
Stop using the product immediately. Contact the manufacturer for additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Compromised sterility due to packaging defect
When was this product recalled?
This product was recalled on May 31, 2024.
Is the Cook, Inc. brand affected by this recall?
Yes, Cook, Inc. products are affected by this recall. This recall involves Cook Medical Needles, Peel-Away® Introducers, and Dilators sold in Canada. They are being recalled because their packaging seals may not meet specifications, which could compromise the sterility of the devices. Healthcare professionals should contact the manufacturer for more information.