| Class 2 Device Recall American Contract Systems | |
Date Initiated by Firm | September 01, 2023 |
Date Posted | October 26, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0173-2024 |
Recall Event ID |
93086 |
Product Classification |
Plastic surgery and accessories kit - Product Code FTN
|
Product | Breast Plastics Pack, REF BBPL20D |
Code Information |
UDI/DI 00191072166241, Lot Numbers: 756221, 782221, 862221 |
Recalling Firm/ Manufacturer |
American Contract Systems, Inc. 7802 E Telecom Pkwy Temple Terrace FL 33637-0928
|
For Additional Information Contact | Marlene Jones 470-280-4277 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 20 cases |
Distribution | US Nationwide distribution in the states of FL, IA. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|