Recall Z-0938-2023— Stradis Healthcare

Name: FDA recall Z-0938-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-15

Class II · Ongoing

Class II FDA medical device recall by Stradis Healthcare, initiated 2022-12-15. It names one FDA 510(k) clearance: K102969. Product: HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.. Reason: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit..

Recalling firm: Stradis Healthcare
Classification: Class II
Status: Ongoing
Initiated: 2022-12-15
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K102969 — IMC PISTON SYRINGESInternational Medsurg Connection·cleared 2010-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.

Reason for recall

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Data sourced from openFDA. This site is unofficial and independent of the FDA.