Product Safety Recalls

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American Contract Systems, Inc. Recall 89868

Description: ACS Cath Lab Pack

American Contract Systems, Inc. Recall 89868 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1040-2022
Event ID89868
Event DescriptionACS Cath Lab Pack
Product TypeDevices
DistributionUS Nationwide distribution in the states of IL, MO, NE, and TX.
Quantity10 packs
Recall ReasonProduct was sterilized with a higher than specification EO concentration.
Device Classification20220518
Device Code InfoModel FTCL83K, Lot 982221 UDI: 00191072151360
Center Classification Date20220506
Recall Initiation Date20220322
Recalling FirmAmerican Contract Systems, Inc.
Initial Notification Letter
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