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HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F

FDA Recall #Z-2300-2024 — Class II — May 15, 2024

Recall #Z-2300-2024 Date: May 15, 2024 Classification: Class II Status: Ongoing

Product Description

HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F

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

352 units

Distribution

US Nationwide distribution.

Code Information

UDI-DI: 00191072192349 LOT#"s: 662231 981241 917241 882241

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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