Device recall
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
- Recall number
- Z-3003-2026
- Event id
- 99514
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- American Contract Systems Inc
- Report date
- Sep 2, 2026
- Posted
- Aug 21, 2026
- Initiated
- Jun 29, 2026
- Center classification date
- Aug 21, 2026
- Product code
- OEZ
- Device type
- Cardiovascular Procedure Kit
- Reason
- The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
- Root cause
- Nonconforming Material/Component
- Quantity
- 12 units
- Code info
- Lot Code: Lot Number: 70-054952 UDI: 191072219947
- Distribution
- US Nationwide distribution in the states of IA, OH.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Tiffin, OH, United States