ConMed recalls sterile surgical pouches (TRS190SB2) manufactured April 2018-Feb 2019 that may have compromised sterility due to seal defects, risking infection during laparoscopic surgery.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
ConMed is recalling sterile surgical pouches used in laparoscopic procedures that may have seal defects, potentially compromising sterility and increasing infection risk during surgery.
The pouch seal may have voids or partial seals, creating an open channel that could allow contamination. This compromises the product's sterility, which is critical for preventing infections during minimally invasive surgery.
Surgical teams using the ConMed Anchor Tissue Retrieval System (TRS190SB2) for laparoscopic procedures are affected. Patients undergoing surgery with this specific product are at risk of infection if the pouch's sterility is compromised.
Check for the catalog number TRS190SB2 on the pouch. The product was manufactured between April 26, 2018 and February 15, 2019, with specific lot codes excluded as listed in the recall notice.
Verify the catalog number TRS190SB2 and lot code on the pouch to confirm if it's affected.
The recall is due to potential voids or partial seals in the pouch that could compromise sterility, increasing infection risk during surgery.
Excluded lot codes include specific numeric codes ending with 9 and the listed codes: 201807114, 201807275, 201807175, 201807304.
The recall notice does not specify a remedy; affected users should check their product details and contact ConMed for further guidance.
We’ve drafted a message you can send ConMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1306-2019 — ConMed ConMed Hello, I own a ConMed that is covered by recall Z-1306-2019 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.
