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Cath Cardiac Pack (American Contract) – component investigation (2023)

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.

Moderate

FDASep 1, 2023Nationwide• American Contract Systems, Inc.

Segmental Stem Canal Filling 152MM (Onkos Surgical) – Tyvek seal breach (2023)

Potential for breach of Tyvek seals.

Low

FDASep 1, 2023AZ, FL, GA +16 more• Onkos Surgical, Inc.

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Cath Cardiac Pack (American Contract) – component investigation (2023)

Segmental Stem Canal Filling 152MM (Onkos Surgical) – Tyvek seal breach (2023)

Segmental Stem Cemented 100MM (Onkos Surgical) – Tyvek seal breach (2023)

Segmental Stem 152MM (Onkos Surgical) – Tyvek seal breach (2023)

Sub Q Recorder Pack (American Contract) – component investigation (2023)

Segmental Stem Canal Filling 120MM (Onkos Surgical) – Tyvek seal breach (2023)

Vasc. Open CVOR SJH Pack (American Contract) – component investigation (2023)

Ethos Collar Stem 100MM (Onkos Surgical) – Tyvek seal breach (2023)

LAVH Pack (American Contract) – component investigation (2023)

Guardian System (Angel Medical) – premature service end (2023)

Pediatric Urology Wolson Pack (American Contract) – component investigation (2023)

Solea Laser Surgical Instrument (Convergent Dental) – unintended activation (2023)

Robotics Pack (American Contract) – component investigation (2023)

Robotics Pack (American Contract) – component investigation (2023)

Male-Female Midsection (Onkos Surgical) – Tyvek seal breach (2023)

General Pack (American Contract) – component investigation (2023)

Pediatric Heart SJH Pack (American Contract) – component investigation (2023)

Zephyr Endobronchial Valve (Pulmonx) – expiration date labeling (2023)

EarlyVue VS30 Vitals Monitor (Philips) – respiration rate alarm issue (2023)

HydroPICC 5Fr Dual Lumen Kit (Access Vascular) – incorrect IFU (2023)