Recall Z-0183-2020— Andover Healthcare Inc.
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 Med 3" - 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 Med 3" - 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.