American Contract Systems Convenience Kit Recall Over Red Rubber Catheter Performance
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American Contract Systems Inc is recalling 30 units of CV B PACK convenience kits because included Medline Red Rubber Intermittent 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 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 initiated a voluntary recall of certain convenience kits after Medline Industries, LP identified that representative samples of the included Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays did not meet applicable performance specifications.
Which Products Are Affected
The recall involves the American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM. Affected units total 30 and are identified by Lot Number: 42-8493811, UDI: 191072232991, and Expiration Date: 7/15/2026. Distribution was limited to US Nationwide in the states of IA and OH.
What You Should Do
Consumers possessing the affected products should refer to the recall notice from American Contract Systems Inc for return or further guidance.
Why This Matters
This Class II recall involves devices that may cause temporary or reversible adverse health consequences if the catheters fail to perform as specified.
Source
FDA Enforcement Report, recall number Z-3000-2026 (event ID 99514).
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.
Similar body length
Nearest notices by article body length (1,079 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.