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Smiths Medical Asd Inc Recall 93506

Description: 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

Smiths Medical Asd Inc Recall 93506 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0747-2024
Event ID93506
Event Description48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Canada, UAE.
Quantity31,685 total
Recall ReasonThere is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device s O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Device Classification20240124
Device Code InfoLot Number: 4383431 4387987 4404698
Center Classification Date20240117
Recall Initiation Date20231110
Recalling FirmSmiths Medical Asd Inc
Initial Notification Letter
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