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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
Related recalls
Same manufacturer · American Contract Systems Inc
See all →- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
Same hazard · performance failure
See all →- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateRemel Neisseria meningitidis Gp C In Vitro Diagnostics Recall
FDA (Devices) · 2026-08-19
- HighSpinal decompression implants recalled after review found instrument and device breakage
FDA (Devices) · 2025-09-10
- HighMedical Device Reagent Recall Due to Storage Condition Exceedance
FDA (Devices) · 2023-01-11
- HighETEST Tobramycin Susceptibility Test Recalled for Storage Condition Failure
FDA (Devices) · 2023-01-11
Similar recalls
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- HighAmerican Contract Systems Recalls ENT Medical Convenience Kits Due to Sterilization Concerns
FDA (Devices) · 2024-10-02
- HighAmerican Contract Systems Recalls Open Shoulder Medical Convenience Kits
FDA (Devices) · 2024-10-02
- HighMedical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination
FDA (Devices) · 2025-06-18
- HighNasal Sinus Pack Recalled Due to Sterilization Verification Failure
FDA (Devices) · 2024-10-02