Z-3001-2026 Class II Ongoing
FDA device recall Z-3001-2026 was initiated by American Contract Systems Inc on June 29, 2026 and is designated Class II. Reason for recall: 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 me… The recall status is ongoing. Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- June 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of IA, OH.
Code Information
Lot Code: Lot Number: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027