Stradis Healthcare recalls neonatal PICC trays with potential pinhole leaks causing sterility breaches. Affected units include specific lot numbers and assembly codes. Stop using immediately to prevent infection risks.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Stradis Healthcare is recalling neonatal PICC trays that may have pinhole leaks in the outer bag, risking a breach in sterility. This could lead to infections for newborns if the tray is used without proper sterility.
The outer bag may develop pinhole leaks near the seal, which can compromise the sterility of the tray. If the tray is used without a sterile environment, it could lead to infections in newborns.
Newborn infants receiving care using the recalled neonatal PICC trays are most at risk. Healthcare providers using the affected units should check their lot numbers.
Check for the assembly number MAG-3000 and lot numbers 220883387, 221226000, 220960490, 220986568, 222074682, or 222458932. The product is sold in cases of 20 trays.
Look for lot numbers 220883387, 221226000, 220960490, 220986568, 222074682, or 222458932 on the tray packaging.
If you have the recalled lot numbers, stop using the neonatal PICC tray to prevent sterility breaches.
The outer bag may have pinhole leaks near the seal, which can compromise the sterility of the tray and lead to infections in newborns.
Check for assembly number MAG-3000 and lot numbers 220883387, 221226000, 220960490, 220986568, 222074682, or 222458932.
Stop using the tray immediately to prevent sterility breaches. Check the lot numbers on the packaging.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0942-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0942-2023 from Stradis Healthcare. 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.
