CLASS II Device recall · Reported 30 Oct 2019 · FDA Enforcement Report
Sterile Co-Flex Med 4" recalled by Andover Healthcare
Andover Healthcare is recalling Sterile Co-Flex Med 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
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-0184-2020
- 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
- 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 Med 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 CaliforniaFloridaIllinoisMassachusettsMinnesotaMissouriNebraskaNew YorkOhioRhode IslandSouth DakotaTexasUtahVirginia
Questions about this recall
Why was it recalled?
Incomplete packaging seal of sterile product
Which lots are affected?
Manufacturer's product or Catalog # 7400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0X0D, CI18K8, CI1DXN
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 83239This product is part of a recall event; the main page for the event is Sterile Co-Flex NL 3" recalled by Andover Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sterile Co-Flex NL 3" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide | |
| CLASS II | Sterile Co-Flex LF2 3" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide | |
| CLASS II | Sterile Co-Flex Med 3" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide | |
| CLASS II | Sterile Co-Flex NL 4" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide | |
| CLASS II | Sterile Co-Flex LF2 4" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide |
More recalls from Andover Healthcare
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage recalled | Andover Healthcare | Sterility | Nationwide |
| Device | CLASS II | Sterile Co-Flex LF2 4" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide |
| Device | CLASS II | Sterile Co-Flex NL 4" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide |
| Device | CLASS II | Sterile Co-Flex Med 3" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide |
| Device | CLASS II | Sterile Co-Flex LF2 3" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |