Recall Z-0180-2024
American Contract Systems, Inc. · initiated September 1, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sub Q Recorder Pack, REF BPRC87A
Codes / lots: UDI/DI 00191072187970, Lot Numbers: 969231
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: Process control
Action taken
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.
Details
- Recall number
- Z-0180-2024
- Initiated
- September 1, 2023
- Posted by FDA
- October 26, 2023
- Product code
- OES – Cardiac Catheterization Kit
- Quantity
- 96 cases
- Distribution
- US Nationwide distribution in the states of FL, IA.
- Recalling firm
- American Contract Systems, Inc., Temple Terrace, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0171-2024 Class II | General Pack, REF BBGP31CDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0172-2024 Class II | LAVH, REF BBLV21CDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0173-2024 Class II | Breast Plastics Pack, REF BBPL20DDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0174-2024 Class II | Robotics Pack SAH, REF SAR530MDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0175-2024 Class II | CVS PCSU SJH, REF SJCV48JDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0176-2024 Class II | Pediatric Heart SJH, REF SJPH34KDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0177-2024 Class II | Vasc. Open CVOR SJH, REF SJVO56BDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0178-2024 Class II | Robotics Pack, REF SJVO56BDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0179-2024 Class II | Robotics Pack, REF SSRO22DDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0181-2024 Class II | Pediatric Urology Wolson Pack, REF BPPU55ADuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0182-2024 Class II | Cath Cardiac Pack, REF IHCC03VDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |