Recall Z-0265-2019— Custom Healthcare Systems, Inc.

Name: FDA recall Z-0265-2019
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: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL. 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: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL

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.