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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 200
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
Part of a larger recall action
This product is one of 18 recalled by Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
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