Class II
Medical Device Recall: Pacemaker, COPM11B; Medical convenience kit
American Contract Systems, Inc. · August 7, 2024
Reason for Recall
ACS 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.
Distribution
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
States Affected
NATIONWIDE
Quantity Affected
3 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3244-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.