American Contract Systems Convenience Kits Recall Over Red Rubber Catheter Specifications

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

American Contract Systems Inc is recalling 30 units of CV B PACK convenience kits containing non-compliant Medline catheters.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on September 10, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated 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.", distributed us nationwide distribution in the states of ia, oh.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

American Contract Systems Inc is recalling certain Convenience Kits because they contain Medline Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP identified that representative samples did not meet applicable performance specifications.

Which Products Are Affected

American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP. Lot Number: 42-8808611, UDI: 191072241252, Expiration Date: 1/6/2027. 30 units distributed nationwide in IA and OH.

What You Should Do

The recall was initiated voluntarily by the firm via letter. Consumers should contact American Contract Systems Inc regarding the affected products.

Why This Matters

This Class II recall involves devices that may cause temporary or reversible adverse health consequences due to catheters not meeting performance specifications.

Source

FDA recall number Z-3002-2026

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
American Contract Systems Inc is recalling 30 units of CV B PACK convenience kits containing non-compliant Medline catheters.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "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." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.