Stradis Healthcare recalls sterile neonatal PICC trays with potential pinhole leaks causing sterility breaches. Affected units include specific assembly numbers and lot numbers. 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 sterile neonatal PICC trays that may have pinhole leaks near the seal. This could breach the sterility of the kit, risking infection for newborns during medical procedures.
The outer bag may develop pinhole leaks near the seal, which can compromise the sterility of the sterile kit. If the kit is not sterile, it could lead to infections in newborns during medical procedures.
Newborns receiving medical care using these sterile PICC trays are at risk. Healthcare providers who have the affected units should stop using them immediately.
Check for assembly number VCP16515-1, UDI-DI: M765VCP1651511, and lot number 221925083 on the product packaging. These specific units were manufactured for Vital Care Products, Inc.
Discard the affected neonatal PICC trays to prevent potential sterility breaches.
The recall is due to potential pinhole leaks in the outer bag near the seal, which could breach the sterility of the kit.
Units with assembly number VCP16515-1, UDI-DI: M765VCP1651511, and lot number 221925083.
Check the product packaging for assembly number VCP16515-1, UDI-DI: M765VCP1651511, and lot number 221925083.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0948-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0948-2023 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.
