FDA Medical Device Recalls (openFDA)
Stradis Healthcare: Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
- Recall number
- Z-0948-2023
- Recalling firm
- Stradis Healthcare
- Product
- Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
- Status
- Open, Classified
- Initiated
- 2022-12-15
- Posted
- 2023-01-11
- Terminated
- not on file
- Reason
- Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- Root cause
- Process control
- Action
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Quantity
- 200 units
- Distribution
- US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
- Lot, serial or model codes
- Assembly Number VCP16515-1, UDI-DI: M765VCP1651511, Lot Number: 221925083
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OWL
- Firm FEI
- 1450943
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28