Device recall
Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A
- Recall number
- Z-0069-2027
- Event id
- 99491
- Status
- Ongoing
- FDA classification
- Class III
- Recalling firm
- Medical Action Industries, Inc. 306
- Report date
- Oct 14, 2026
- Posted
- Oct 2, 2026
- Initiated
- Jul 9, 2026
- Center classification date
- Oct 2, 2026
- Product code
- OIE
- Device type
- Urine Collection Kit (Excludes Hiv Testing)
- Reason
- An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
- Root cause
- Labeling design
- Quantity
- 4000
- Code info
- Lot Code: Lot Number: 333606 UDI: 20809160118228 Expiration Date: 3/31/2027
- Distribution
- U.S.: CA O.U.S.: N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Arden, NC, United States