Z-0184-2020Class II

Sterile Co-Flex Med 4" -

Name: Z-0184-2020 Sterile Co-Flex Med 4" -
Creator: Andover Healthcare Inc.
Published: 2019-06-19
License: https://open.fda.gov/license/

Andover Healthcare Inc. / initiated 2019-06-19 / Terminated / root cause: packaging

FDA source

Andover Healthcare Inc. began a recall of Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap on 2019-06-19. FDA classified it as Class II and gives the reason as "Incomplete packaging seal of sterile product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0184-2020
Classification: Class II
Status: Terminated
Initiated: 2019-06-19
Posted: 2019-10-23
Terminated: 2020-09-09
Recalling firm: Andover Healthcare Inc.
Product: Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Product code: FQM Bandage, Elastic
Reason for recall: Incomplete packaging seal of sterile product
Root cause tag: packaging
FDA root cause: Packaging
Action: 1. Identify and return all 3" and 4" sterile CoFlex products (Nl, LF2, AFD, MED) made between October 1, 2018 and June 14, 2019. 2. Discontinue the distribution and use of all 3" and 4" sterile Coflex product (Nl, LF2, AFD, MED) 3. Fax, phone, or email the acknowledgement of this recall notice to Fax: 978-499-0826, Email: [email protected], Phone:1(800)432-6686 For further information, questions, or concerns reach out to Andover Healthcare at: Phone: 1 (800) 432-6686, Monday through Friday 8 AM to 4:30 PM Eastern Time.
Quantity in commerce: 1050 Cases
Distribution: US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA
Product codes and lots: Manufacturer's product or Catalog # 7400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0X0D, CI18K8, CI1DXN

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0184-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0179-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23
Z-0180-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23
Z-0181-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23
Z-0182-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23
Z-0183-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23
Z-0184-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23

Product code FQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)