American Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
American Contract Systems Inc is recalling 30 units of Convenience Kits because the included Medline catheters did not meet 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 voluntary precautionary recall.
Plain-English summary
American Contract Systems Inc is recalling 30 units of the American Contract System Convenience Kit, CV B PACK (Model/Catalog Number: TNCB10AN). The affected units are identified by Lot Number 42-8768511, UDI 191072239907, and have an expiration date of 1/6/2027. These kits were distributed nationwide in the states of Iowa and Ohio.
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 FDA has classified this recall as Class II.
Consumers who possess these specific kits should stop using them and contact American Contract Systems Inc for further instructions.
The recalled product
- Product
- American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
- 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: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027
Distribution
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