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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)

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

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

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

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

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

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

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

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

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

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

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

TRP Natural Eyes Dryness Relief PF (Amman Pharmaceuticals) – sterility concern (2023)

TRP Natural Eyes Red Eye Relief (Amman Pharmaceuticals) – sterility concern (2023)

Octiq Lubricating Eye Drops (Amman Pharmaceuticals) – sterility concern (2023)

TRP Natural Eyes Blur Relief (Amman) – Sterility Concern (2023)

TRP Natural Eyes Eye Lid Relief (Amman Pharmaceuticals) – sterility concern (2023)

TRP Natural Eyes Twitching Relief (Amman Pharmaceuticals) – sterility concern (2023)

TRP Natural Eyes Pink Eye Relief PF (Amman Pharmaceuticals) – sterility concern (2023)