American Contract System Convenience Kits
American Contract System Convenience Kits did not meet applicable performance specifications.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
American Contract Systems Inc, of Tiffin, Ohio, recalled Convenience Kits containing Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP identified that representative samples did not meet applicable performance specifications. The recall began on June 29, 2026, and was added to the FDA's Enforcement Report on August 21, 2026.
The kits were distributed in Iowa and Ohio.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match your product and all the details in one listed combination.
American Contract System Convenience Kits, CV B Pack, Model/
- UDI-DI
- 191072241252
- Catalog code
- TNCB10AP
- Lot
- 42-8808611
American Contract System Convenience Kit, D & C Pack, Model/
- UDI-DI
- 191072219947
- Catalog code
- LLPD90H
- Lot
- 70-054952
American Contract System Convenience Kit, CV B Pack, Model/
- UDI-DI
- 191072232991
- Catalog code
- TNCB10AM
- Lot
- 42-8493811
- UDI-DI
- 191072239907
- Catalog code
- TNCB10AN
- Lot
- 42-8768511
Details
- Company began the recall
- Event ID
- 99514
- Recall numbers
- Z-3000-2026 to Z-3003-2026
- Company
- American Contract Systems IncTiffin, Ohio
- Hazard
- Failed specifications
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
