ConMed recalls sterile surgical pouches with potential sterility compromise due to seal defects. Affected units manufactured April 2018 to February 2019; check lot codes for exclusions.
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 because seal defects could compromise sterility. This risk could lead to infections during surgery if the pouch is not properly sterile.
The pouch seal may develop voids or partial seals, creating an open channel that allows contamination. This could compromise the sterility of the product during surgery, potentially leading to infections.
Surgical teams using ConMed Anchor Tissue Retrieval Systems for laparoscopic procedures. Patients undergoing surgery with these devices face the risk of infection if the pouch is not sterile.
Check the lot code on the pouch. Units manufactured between April 26, 2018 and February 15, 2019 with specific excluded lot codes (e.g., 20180426X to 20190215X) are affected. Exclude lots starting with alphanumeric characters or ending with '9'.
Look for the lot code on the pouch, which ranges from 20180426X to 20190215X for affected units.
The pouch seal may have voids or partial seals, creating an open channel that could compromise sterility and lead to infections during surgery.
Units manufactured between April 26, 2018 and February 15, 2019 with lot codes from 20180426X to 20190215X, excluding specific alphanumeric or numeric lots ending with '9'.
Check the lot code on the pouch. Affected units have lot codes starting from 20180426X to 20190215X, but exclude lots starting with alphanumeric characters or ending with '9' as 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-1305-2019 — ConMed ConMed Hello, I own a ConMed that is covered by recall Z-1305-2019 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.
