Recall Z-0936-2023— Stradis Healthcare

Name: FDA recall Z-0936-2023
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: K190328. Product: HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. 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

K190328 — HCT Empty EVA Container PackHealth Care Technologies·cleared 2019-08-15

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 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. 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.