CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
ENT, COEN27N recalled by American Contract Systems
American Contract Systems is recalling ENT, COEN27N, distributed nationwide in the US. The recall was initiated on 7 Aug 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-3241-2024
- FDA event ID
- 95261
- Recalling firm
- American Contract Systems, Kansas City, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Aug 2024
- FDA classified
- 24 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 7 Aug 2024 | Recall initiated by company | |
| 24 Sep 2024 | Classified by FDA | +48 days |
| 2 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
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
ENT, COEN27N; Medical convenience kit
Where it was distributed
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Questions about this recall
Is ENT, COEN27N recalled?
Yes. American Contract Systems recalled ENT, COEN27N on 7 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-3241-2024.
Why was it recalled?
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Which lots are affected?
UDI-DI: 00191072206244; Lot: 2405092; Exp: 05/09/2025
Where was it sold?
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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 American Contract Systems
All 210| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, D & C PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | medical procedure kits and trays labeled as: Crani Pack recalled | American Contract Systems | Sterility | IA, MN, MO |
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 |