CLASS II Device recall · Reported 30 Oct 2019 · FDA Enforcement Report

Sterile Co-Flex LF2 4" recalled by Andover Healthcare

Andover Healthcare is recalling Sterile Co-Flex LF2 4", distributed nationwide in the US. The recall was initiated on 19 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesManufacturer's product or Catalog # 9400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI147V, CI15F1, CI17B9, CI18Y0, CI1FJ3, CI1JCF

Quantity recalled1759 Cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0182-2020
FDA event ID: 83239
Recalling firm: Andover Healthcare, Salisbury, MA
Classification: Class II
Status: Terminated
Recall initiated: 19 Jun 2019
FDA classified: 23 Oct 2019
Reported: 30 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

19 Jun 2019	Recall initiated by company
23 Oct 2019	Classified by FDA	+126 days
30 Oct 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incomplete packaging seal of sterile product

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Where it was distributed

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

Nationwide California Florida Illinois Massachusetts Minnesota Missouri Nebraska New York Ohio Rhode Island South Dakota Texas Utah Virginia

Questions about this recall

Is Sterile Co-Flex LF2 4" recalled?

Yes. Andover Healthcare recalled Sterile Co-Flex LF2 4" on 19 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-0182-2020.

Why was it recalled?

Incomplete packaging seal of sterile product

Which lots are affected?

Manufacturer's product or Catalog # 9400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI147V, CI15F1, CI17B9, CI18Y0, CI1FJ3, CI1JCF

Where was it sold?

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Andover Healthcare

All 7

Reported	Class	Recall	Company	Reason	Where
22 May 2024Device	CLASS II	Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage recalled	Andover Healthcare	Sterility	Nationwide
30 Oct 2019Device	CLASS II	Sterile Co-Flex Med 4" recalled by Andover Healthcare	Andover Healthcare	Sterility	Nationwide
30 Oct 2019Device	CLASS II	Sterile Co-Flex NL 4" recalled by Andover Healthcare	Andover Healthcare	Sterility	Nationwide
30 Oct 2019Device	CLASS II	Sterile Co-Flex Med 3" recalled by Andover Healthcare	Andover Healthcare	Sterility	Nationwide
30 Oct 2019Device	CLASS II	Sterile Co-Flex LF2 3" recalled by Andover Healthcare	Andover Healthcare	Sterility	Nationwide

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