Recall Z-0180-2020— Andover Healthcare Inc.

Name: FDA recall Z-0180-2020
Creator: U.S. Food and Drug Administration
Published: 2019-06-19

Class II · Terminated

Class II FDA medical device recall by Andover Healthcare Inc., initiated 2019-06-19, terminated 2020-09-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap. Reason: Incomplete packaging seal of sterile product.

Recalling firm: Andover Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-19
Terminated: 2020-09-09
Firm location: Salisbury, MA, United States

Product description

Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Reason for recall

Incomplete packaging seal of sterile product

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