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ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A

FDA Recall #Z-2280-2024 — Class II — May 15, 2024

Recall #Z-2280-2024 Date: May 15, 2024 Classification: Class II Status: Ongoing

Product Description

ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A

Reason for Recall

Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

Recalling Firm

American Contract Systems Inc — Tiffin, OH

Classification

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

Product Type

Devices

Product Quantity

96 units

Distribution

US Nationwide distribution.

Code Information

UDI-DI: 00191072187444 LOT#"s: 661231 971241 928241 893241

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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