Waukegan, IL, United States
Stradis Healthcare recalls
3 recalls recorded since 2018, most recently on 15 December 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 December 2022
- Reason
- Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- Distribution
- US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0943-2023, Z-0938-2023, Z-0939-2023, Z-0944-2023, Z-0941-2023, Z-0946-2023, Z-0931-2023, Z-0948-2023, Z-0932-2023, Z-0937-2023, Z-0934-2023, Z-0942-2023 and 6 more
- McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
- HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
- HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
- Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
- HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
- Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
- Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
- Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
- and 10 more product lines
Ongoing Class II Medical devices
- Recall started
- 10 May 2022
- Reason
- Potential for incomplete seals.
- Distribution
- Pennsylvania
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1688-2022
- VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Terminated Class II Medical devices
- Recall started
- 22 April 2022
- Terminated
- 22 September 2026
- Reason
- There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
- Distribution
- US Distribution to NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1132-2022
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.