W. L. Gore recalls sterile 14Fr DrySeal Flex Introducer Sheaths mislabeled as 14Fr when they are 16Fr. Check serial numbers for affected units.
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
W. L. Gore is recalling sterile 14Fr DrySeal Flex Introducer Sheaths that were mislabeled as 14Fr when they are actually 16Fr. This mislabeling could lead to incorrect use in medical procedures.
The sheaths were labeled as 14Fr (smaller diameter) but are actually 16Fr (larger diameter). Using the wrong size could cause improper insertion or complications during medical procedures.
Healthcare professionals using these sheaths for medical procedures are most at risk. Patients receiving procedures with mislabeled sheaths could face complications.
Check for the product name 'Gore DrySeal Flex Introducer Sheath', catalog number DSF1433, and serial numbers listed in the recall notice. The sheaths are sterile and 33cm long.
Compare your sheath's serial number against the list of affected serial numbers provided in the recall notice.
The sheaths were mislabeled with the incorrect product size, resulting in 16Fr devices being labeled as 14Fr devices.
Check your serial number against the list of affected serial numbers provided in the recall notice.
The recall does not provide a fix; affected units must be checked against the serial number list.
We’ve drafted a message you can send W. L. Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-1962-2020 — W. L. Gore W. L. Gore Hello, I own a W. L. Gore that is covered by recall Z-1962-2020 from W. L. Gore. 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.
