FDA Media Alert Detail

Device Recall

FDA Device Recall: American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H

  • U.S. Food and Drug Administration
  • September 2, 2026
  • ID: device-Z-3003-2026

Device Enforcement Report Details

Recall NumberZ-3003-2026
Recalling FirmAmerican Contract Systems Inc
ClassificationClass II
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternUS Nationwide distribution in the states of IA, OH.
StatusOngoing
Device ClassN/A
Device NameN/A
Product Description

American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H

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.

Code Information

Lot Code: Lot Number: 70-054952 UDI: 191072219947


Content syndicated from the U.S. Food and Drug Administration (FDA) device enforcement reports database.