American Contract Systems Convenience Kit Recall

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 12 units of its D & C PACK Convenience Kit (Model LLPD90H) because contained catheters did not meet performance specifications.

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

This notice was issued by FDA on September 9, 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

The recall was initiated because the Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Representative samples did not meet applicable performance specifications.

Which Products Are Affected

American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H. Lot Number: 70-054952. UDI: 191072219947. 12 units distributed nationwide in IA and OH. Recall number Z-3003-2026. Classification: Class II.

What You Should Do

Consumers should contact the recalling firm regarding the affected product.

Why This Matters

This ongoing Class II recall involves medical devices distributed in the United States that may not meet performance specifications.

Source

FDA recall number Z-3003-2026, report date 20260902.

Original source: FDA Official Notice ↗

All FDA Recalls →

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 12 units of its D & C PACK Convenience Kit (Model LLPD90H) because contained catheters did not meet performance specifications.
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.