CLASS I ONGOING Device recall · Reported 13 Jul 2022 · FDA Enforcement Report
Clean Catch Urine Kit NS 178489, AHMU58A recalled
American Contract Systems is recalling Clean Catch Urine Kit NS 178489, AHMU58A, distributed in Minnesota. The recall was initiated on 2 May 2022 and the FDA has classified it as Class I.
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-1276-2022
- FDA event ID
- 90324
- Recalling firm
- American Contract Systems, Kansas City, MO
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 2 May 2022
- FDA classified
- 1 Jul 2022
- Reported
- 13 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 May 2022 | Recall initiated by company | |
| 1 Jul 2022 | Classified by FDA | +60 days |
| 13 Jul 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected products were assembled off-site by individuals who may not have been properly trained.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Clean Catch Urine Kit NS 178489, AHMU58A
Where it was distributed
US distribution in the state of Minnesota.
Questions about this recall
Is Clean Catch Urine Kit NS 178489, AHMU58A recalled?
Yes. American Contract Systems recalled Clean Catch Urine Kit NS 178489, AHMU58A on 2 May 2022. The recall is Class I and its status is Ongoing. Recall number Z-1276-2022.
Why was it recalled?
Affected products were assembled off-site by individuals who may not have been properly trained.
Which lots are affected?
UDI-DI: 00191072120557 Lots 891211, 737211, 699211, 986221
Where was it sold?
US distribution in the state of Minnesota.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
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