American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
Summary
The FDA issued a Class II for American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB1 by American Contract Systems Inc. Reason: The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, L.
Details
Source
Device Recall
External ID
Z-3000-2026
Action Date
2026-09-02
Status
Ongoing
Category
device
Product Description
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
Lot/Code Info: Lot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026
Quantity Affected: 30 units
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
US Nationwide distribution in the states of IA, OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-29
Company
Tiffin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 445 device-related FDA actions this month.
American Contract Systems Inc has 194 FDA actions in our database, including 194 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems Inc have FDA actions?
American Contract Systems Inc has 194 FDA actions in our database, including 194 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3000-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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