FDA-Device2023-01-18Class II

McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.

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
250 units
Manufactured in
3600 Burwood Dr, Waukegan, IL, United States
Products
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2023

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