Product Safety Recalls

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American Contract Systems, Inc. Recall 95261

Description: Pacemaker, COPM11B; Medical convenience kit

American Contract Systems, Inc. Recall 95261 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-3244-2024
Event ID95261
Event DescriptionPacemaker, COPM11B; Medical convenience kit
Product TypeDevices
DistributionUS Nationwide distribution in the states of MO, MN, MA, OH, NE.
Quantity3 units
Recall ReasonACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Device Classification20241002
Device Code InfoUDI-DI: 00191072206312; Lot: 2405033; Exp: 05/03/2025
Center Classification Date20240924
Recall Initiation Date20240807
Recalling FirmAmerican Contract Systems, Inc.
Initial Notification E-Mail
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