ConMed recalls surgical tissue retrieval pouches (TRS-ROBO-12) manufactured between April 2018 and February 2019 due to potential sterility compromise from seal defects.
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 could have seal defects, risking contamination during laparoscopic procedures. This affects surgeons and hospitals using the specific model and production dates listed.
The pouch seal may have voids or partial seals, creating an open channel that could compromise sterility during surgery. This might lead to contamination of the surgical site if the pouch is not properly sealed.
Surgeons and hospitals using the ConMed Anchor Tissue Retrieval System (12 MM, 300 ML) with catalog number TRS-ROBO-12 manufactured between April 26, 2018 and February 15, 2019 are most at risk.
Check for the catalog number TRS-ROBO-12 on the pouch. Look for lot codes between 20180426X and 20190215X, excluding specific numeric lot codes ending with 9 or listed in the exclusion tables.
Identify the catalog number TRS-ROBO-12 and lot code on the pouch to confirm 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 like 201901084, 201901104, 201901144, 201901094, 201901114 for catalog number TRS-ROBO-12.
Check for catalog number TRS-ROBO-12 with lot codes between 20180426X and 20190215X, excluding specific numeric lot codes ending with 9 or listed in the exclusion tables.
We’ve drafted a message you can send ConMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1309-2019 — ConMed ConMed Hello, I own a ConMed that is covered by recall Z-1309-2019 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.
