Product Safety Recalls

Product Recall Tracker

American Contract Systems Inc Recall 94765

Description: ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C

American Contract Systems Inc Recall 94765 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2281-2024
Event ID94765
Event DescriptionARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity272 units
Recall ReasonEthylene 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.
Device Classification20240717
Device Code InfoUDI-DI: 00191072197825 LOT#"s: 665231 950241
Center Classification Date20240705
Recall Initiation Date20240515
Recalling FirmAmerican Contract Systems Inc
Initial Notification E-Mail
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.