Medtronic recalls specific lots of Custom Pack 1/4 Respirato perfusion systems due to potential insufficient welds. Affected units may have manufacturing defects that could lead to leaks or failure during use.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling specific lots of Custom Pack 1/4 Respirato perfusion systems because some units may have been manufactured with insufficient or incomplete welds. This could lead to leaks or system failure during medical use, posing a risk to patients.
Insufficient or incomplete welds in the perfusion system could cause leaks or system failure during medical use. This might lead to improper delivery of medical fluids or other complications for patients.
Patients using Medtronic Custom Pack 1/4 Respirato perfusion systems with the specified lot numbers and GTIN are affected. Healthcare providers and patients who use these systems are at risk if the welds are insufficient.
Check for the lot numbers 220911913 (Use By 2022-03-13) or 221249923 (Use By 2022-10-01) on the packaging. The product has a GTIN of 00763000314231 and is labeled as a Custom Pack 1/4 Respirato perfusion system.
Look for the lot numbers 220911913 or 221249923 on the packaging of the Custom Pack 1/4 Respirato perfusion system.
Medtronic Custom Pack 1/4 Respirato perfusion systems with lot numbers 220911913 (Use By 2022-03-13) or 221249923 (Use By 2022-10-01).
The recall record does not specify a remedy.
Insufficient or incomplete welds could cause leaks or system failure during medical use, potentially leading to improper fluid delivery or complications.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1877-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1877-2021 from Medtronic. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
