ConMed recalls specific surgical pouches due to potential sterility compromise from seal defects. Affected units manufactured between April 2018 and February 2019 with certain lot codes.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
ConMed is recalling surgical tissue retrieval pouches that may have seal defects, risking contamination during laparoscopic procedures. This could lead to infections if used improperly.
The pouch seal may develop voids or partial seals, creating an open channel that compromises sterility. This could allow contaminants to enter the surgical site during procedures.
Surgical teams using the ConMed Anchor Tissue Retrieval System during laparoscopic procedures. Patients at risk if the pouch is used without proper sterility.
Check the catalog number TRS100SB2 on the pouch. Units manufactured between April 26, 2018 and February 15, 2019 with specific lot codes listed in the recall notice (excluding certain numeric and alphanumeric codes).
Identify the catalog number TRS100SB2 and lot code on the pouch to determine if it's affected.
The pouch seal may have voids or partial seals, creating an open channel that could compromise sterility during surgery.
All numeric lot codes ending with 9, and specific lot codes listed in the recall notice for catalog number TRS100SB2.
Check the catalog number TRS100SB2 and lot code on the pouch. Affected units were manufactured between April 26, 2018 and February 15, 2019 with specific lot codes listed in the recall notice.
We’ve drafted a message you can send ConMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1304-2019 — ConMed ConMed Hello, I own a ConMed that is covered by recall Z-1304-2019 from ConMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.