American Contract System Convenience Kits Recalled for Performance Failures
American Contract Systems Inc is recalling 30 units of Convenience Kits because Medline catheters failed performance specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
American Contract Systems Inc is recalling 30 units of American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP. The affected lot number is 42-8808611, with a UDI of 191072241252 and an expiration date of 1/6/2027.
The recall was initiated because Medline Industries, LP identified that representative samples of the Medline Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays contained in the kits did not meet applicable performance specifications.
The affected products were distributed nationwide in the states of Iowa and Ohio. Consumers should stop using the affected kits and contact the recalling firm for further instructions.
The recalled product
- Product
- American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027
Distribution
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