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American Contract Systems Inc: American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM

Medical DevicesSource: FDA (device) · Date: 2026-09-02

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
American Contract Systems Inc
Product
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of IA, OH.
Recall initiated
2026-06-29
Code info
Lot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026
Product quantity
30 units
Voluntary mandated
Voluntary: Firm initiated
City
Tiffin
State
OH
Country
United States
Event id
99514
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