Cook recalls Mallinckrodt Institute Percutaneous Gastrostomy Sets with backward-loaded wire guides. Affected lots include 6869315, 6908857, 7034661, 7106057, 7193431, 7252317, 7635697, 7744001, 7811587, 8025220, 8076495. Contact Cook for remedy.
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Cook is recalling Mallinckrodt Institute Percutaneous Gastrostomy Sets that may have wire guides loaded backward into the holder. This could cause improper placement during medical procedures, potentially leading to complications for patients needing feeding tubes.
Backward-loaded wire guides could cause the device to malfunction during insertion. This might lead to improper placement of the feeding tube, increasing the risk of complications like infection or injury.
Patients using this medical device for gastroenteric feeding and healthcare providers who may have installed the set. Those with the specific lot numbers are most at risk.
Check the lot numbers on the product: 6869315, 6908857, 7034661, 7106057, 7193431, 7252317, 7635697, 7744001, 7811587, 8025220, 8076495. The product is intended for percutaneous placement of feeding tubes.
Look for the lot numbers listed: 6869315, 6908857, 7034661, 7106057, 7193431, 7252317, 7635697, 7744001, 7811587, 8025220, 8076495.
Cook identified that affected lots may contain wire guides loaded backward into the wire guide holder, which could cause improper placement during medical procedures.
Check the lot number on your product. If it matches the listed numbers, contact Cook for instructions on how to handle the device.
The recall states the hazard could lead to improper placement, but the official notice does not specify if this causes serious injury in normal use.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0830-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-0830-2018 from Cook. 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.
