medical Class II Updated 2023-11-01

American Contract Systems, Inc. recalls Breast Plastics Pack, REF BBPL20D

Recalled Product

Breast Plastics Pack, REF BBPL20D

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 00191072166241, Lot Numbers: 756221, 782221, 862221
View official government recall

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