Medtronic recalls specific custom perfusion system packs due to potential insufficient welds in manufacturing. Affected lots may have safety risks requiring immediate attention.
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic is recalling certain custom perfusion system packs that may have been manufactured with insufficient or incomplete welds. This could pose a safety risk if the device fails during use.
Insufficient welds in the custom packs could lead to leaks or failure of the device during use. This might cause the device to malfunction or become unsafe if the welds are not properly sealed.
Patients using the Medtronic CB7J98R7 custom perfusion systems with the specific lot numbers mentioned are affected. Those with the device in use are at higher risk.
Check for the lot number 221575680 on the packaging or label. The product includes the Medtronic CB7J98R7 Custom Pack, 3/8 Pack, or Sterile Rx versions with the GTIN 00643169640870.
Verify the lot number on the packaging or label to confirm if your device is affected.
The Medtronic CB7J98R7 Custom Pack, 3/8 Pack, and Sterile Rx versions with lot number 221575680.
The recall record does not specify a remedy, so no action is required beyond checking if your device is affected.
Look for the lot number 221575680 on the packaging or label, and check the GTIN 00643169640870.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1889-2021 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1889-2021 from Medtronic Perfusion Systems. 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.
