The Recall Desk
SevereFDA (Devices)·Z-1276-2022·Announced 2022-07-13

Clean Catch Urine Kit Recalled Due to Improper Assembly

American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall, indicating serious potential for harm. Although no illnesses or injuries are reported in the source material, the agency's classification mandates a minimum severity of 4 (Severe).

Plain-English summary

American Contract Systems, Inc. is recalling 274,400 Clean Catch Urine Kits (NS 178489, AHMU58A) distributed in Minnesota. The affected kits are from lots 891211, 737211, 699211, and 986221, with UDI-DI 00191072120557.

The recalled products were assembled off-site by individuals who may not have been properly trained. The FDA classified this as a Class I recall.

Consumers who have received or are using one of these kits should stop use of the affected lots and contact American Contract Systems, Inc. for information on replacement or return of the products.

The recalled product

Product
Clean Catch Urine Kit NS 178489, AHMU58A
Manufacturer
American Contract Systems, Inc.
Category
Medical Device — Urine Collection
Hazard
  • assembly-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • UDI-DI: 00191072120557 Lots 891211
  • 737211
  • 699211
  • 986221

Distribution

Distribution scope not specified by the agency.

Related recalls

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