Recall Z-0250-2019— Custom Healthcare Systems, Inc.

Name: FDA recall Z-0250-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-13

Class II · Terminated

Class II FDA medical device recall by Custom Healthcare Systems, Inc., initiated 2018-08-13, terminated 2022-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02. Reason: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility.

Recalling firm: Custom Healthcare Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-13
Terminated: 2022-08-01
Firm location: Richmond, VA, United States

Product description

CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02

Reason for recall

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

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