American Contract Systems, Inc. Recall: LAVH, REF BBLV21C
American Contract Systems, Inc. Recall: LAVH, REF BBLV21C is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: American Contract Systems, Inc.; Product: LAVH, REF BBLV21C; Reason for recall: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535
| Recalling firm | American Contract Systems, Inc. |
|---|---|
| Product | LAVH, REF BBLV21C |
| Reason for recall | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US Nationwide distribution in the states of FL, IA. |
| Recall initiated | 20230901 |
| Recall number | Z-0172-2024 |
| Category | device |
| State | FL |
| Country | United States |
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