HAND PACK-Procedure Kit Catalog Number: WEHD16B
FDA Recall #Z-2310-2024 — Class II — May 15, 2024
Product Description
HAND PACK-Procedure Kit Catalog Number: WEHD16B
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
135 units
Distribution
US Nationwide distribution.
Code Information
UDI-DI: 00191072188632 LOT#"s: 662231 983241 934241
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.