Recall Z-0173-2024 ยท FTN Plastic Surgery And Accessories Kit
American Contract Systems, Inc.
Breast Plastics Pack, REF BBPL20D
| Date | Oct 26, 2023 (initiated Sep 1, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 09/01/2023 by email. The notice explained the issue, risk, and requested the user discontinue the use of the I.V. Cath and Adhesive Dermabond and affix a warning label to each kit and case of affected product in inventory. The firm sent an updated letter on 09/22/2023 via email which corrected the product distribution date. |
| Quantity | 20 cases |
| Distribution | US Nationwide distribution in the states of FL, IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.