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General Pack, REF BBGP31C

FDA Recall #Z-0171-2024 — Class II — September 1, 2023

Recall #Z-0171-2024 Date: September 1, 2023 Classification: Class II Status: Ongoing

Product Description

General Pack, REF BBGP31C

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.

Recalling Firm

American Contract Systems, Inc. — Temple Terrace, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

57 cases

Distribution

US Nationwide distribution in the states of FL, IA.

Code Information

UDI/DI 00191072166609, Lot Number 968231

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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