Food, drugs, devices › American Contract Systems, Inc.
Device recall: BASIN SET, MEBS42K, general surgical kit
FDA enforcement event 91077 is a device recall by American Contract Systems, Inc. of Kansas City, MO, initiated 12 Oct 2022 and classified Class II, with 1 product record.
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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 6 Mar 2025. 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., Kansas City, MO.
Reason for recall
"Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0274-2023 | BASIN SET, MEBS42K, general surgical kit | 1504 trays | Class II | Terminated | 30 Nov 2022 |
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: "Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label."
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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Mar 2025. "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.