Food, drugs, devices › American Contract Systems Inc
Device recall: American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
FDA enforcement event 99514 is a device recall by American Contract Systems Inc of Tiffin, OH, initiated 29 Jun 2026 and classified Class II, with 4 product records.
FDA defines Class II as 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. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. American Contract Systems Inc has 22 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
American Contract Systems Inc, Tiffin, OH.
Reason for recall
"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."
Distribution
"US Nationwide distribution in the states of IA, OH."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3000-2026 | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM | 30 units | Class II | Ongoing | 2 Sep 2026 |
| Z-3001-2026 | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN | 30 units | Class II | Ongoing | 2 Sep 2026 |
| Z-3002-2026 | American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP | 30 units | Class II | Ongoing | 2 Sep 2026 |
| Z-3003-2026 | American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H | 12 units | Class II | Ongoing | 2 Sep 2026 |
Context
Other enforcement events for American Contract Systems Inc
All 22 events for American Contract Systems Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of IA, OH."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.