Device product
Breast Plastics Pack, REF BBPL20D
Z-0173-2024
Product summary
- Event
- Event 93086
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 cases
- Official record key
device-enforcement:Z-0173-2024
Official wording
Reason: 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.
Code information: UDI/DI 00191072166241, Lot Numbers: 756221, 782221, 862221
Distribution pattern: US Nationwide distribution in the states of FL, IA.
Derived failure modes
-
Unknown
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.