The Recall Desk
HighFDA (Devices)·Z-0948-2023·Announced 2023-01-18

Neonatal PICC Tray Recalled Due to Potential Sterility Breach

Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device with a theoretical risk of sterility breach in neonatal care kits. No illnesses or injuries have been reported. Under the rubric, risk-of-harm products without reported injury score as High (3).

Plain-English summary

Vital Care Products NEONATAL PICC TRAY (Sterile, QTY 20), manufactured by Stradis Healthcare, is being recalled due to the potential for pinhole leaks in the outer bag near the seal. This defect may result in a breach of the kit's sterility.

The affected product (Lot Number: 221925083) was distributed nationwide in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington. A total of 200 units were distributed.

Healthcare facilities and healthcare providers that received affected kits should verify their inventory and determine the status of the affected lot.

The recalled product

Product
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Manufacturer
Stradis Healthcare
Category
Medical Device — Neonatal PICC Administration
Hazard
  • sterility-breach
  • infection-risk
  • packaging-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Assembly Number VCP16515-1
  • UDI-DI: M765VCP1651511
  • Lot Number: 221925083

Distribution

Distributed nationwide across the United States.

Related recalls

Same category