CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage recalled
Andover Healthcare is recalling Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S), distributed nationwide in the US. The recall was initiated on 2 Apr 2024 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-1828-2024
- FDA event ID
- 94394
- Recalling firm
- Andover Healthcare, Salisbury, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Apr 2024
- FDA classified
- 15 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 2 Apr 2024 | Recall initiated by company | |
| 15 May 2024 | Classified by FDA | +43 days |
| 22 May 2024 | 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
A packaging seal gap could impact the sterility of the 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 CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Where it was distributed
US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
Nationwide CaliforniaColoradoGeorgiaIowaIndianaMinnesotaNorth CarolinaOhioPennsylvaniaTexasVirginiaWashington
Questions about this recall
Why was it recalled?
A packaging seal gap could impact the sterility of the product.
Which lots are affected?
Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.
Where was it sold?
US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
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.
More recalls from Andover Healthcare
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sterile Co-Flex LF2 4" recalled by Andover Healthcare | Andover Healthcare | Sterility | Nationwide |
| Device | CLASS II | Sterile Co-Flex Med 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 |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
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