PDS Plus Antibacterial Suture CL, Vl and Vl (Loop) (2019-12-23)
In plain language
This recall involves PDS Plus Antibacterial Suture CL, VL, and VL (Loop) sold in Canada. It's being recalled because certain product codes and lot numbers were distributed with instructions for use that are not approved by Health Canada for pediatric tissue. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Ethicon LLC for more information.
- Follow the instructions provided by Health Canada or your healthcare professional.
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Affected products
PDS Plus Antibacterial Suture CL
Model: PDP443H
Lot: PB5163, PBU274
PDS Plus Antibacterial Suture VL
Model: PDP304H, PDP315H, PDP317H, PDP332H, PDP333H, PDP334H, PDP338H, PDP346H, PDP347H, PDP352H, PDP371T, PDP463G
Lot: More than 10 numbers, contact manufacturer.
PDS Plus Antibacterial Suture VL (Loop)
Model: PDP990G, PDP991G
Lot: More than 10 numbers, contact manufacturer.
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., PB5163, PBU274
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: PDP304H, PDP315H, PDP317H, PDP332H, PDP333H, PDP334H, PDP338H, PDP346H, PDP347H, PDP352H, PDP371T, PDP443H, PDP463G, PDP990G, PDP991G
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?
This recall involves PDS Plus Antibacterial Suture CL, VL, and VL (Loop) sold in Canada. It's being recalled because certain product codes and lot numbers were distributed with instructions for use that are not approved by Health Canada for pediatric tissue. Stop using the product and follow the return steps in the official notice.
What should consumers do?
Stop using the product immediately. Contact Ethicon LLC for more information. Follow the instructions provided by Health Canada or your healthcare professional.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on January 10, 2020.
Is the PDS Plus brand affected by this recall?
Yes, PDS Plus products are affected by this recall. This recall involves PDS Plus Antibacterial Suture CL, VL, and VL (Loop) sold in Canada. It's being recalled because certain product codes and lot numbers were distributed with instructions for use that are not approved by Health Canada for pediatric tissue. Stop using the product and follow the return steps in the official notice.