FDA-Device2023-01-18Class II

HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology

Stradis Healthcare
Hazard

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

Sold states
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Affected count
200 units
Manufactured in
3600 Burwood Dr, Waukegan, IL, United States
Products
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0941-2023

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