Covidien Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product recall — FDA Z-1285-2020
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Overview of recall records associated with Covidien, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 112, Class I: 10.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
Sterilization method used was not consistent with the labeling and the approved sterilization method
Sterilization method used was not consistent with the labeling and the approved sterilization method
Sterilization method used was not consistent with the labeling and the approved sterilization method
The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the…
This page summarizes recall records in which the official source identifies Covidien, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.