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Smiths Medical ASD Inc. Recall 87647

Description: Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.

Smiths Medical ASD Inc. Recall 87647 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1480-2021
Event ID87647
Event DescriptionTubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
Product TypeDevices
DistributionDistribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
Quantity11340 units
Recall ReasonSpecific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
Device Classification20210428
Device Code Infoa. REF 601280, Lot Numbers: 3872300, 3946984 b. REF 601281, Lot Numbers: 3872301, 4024481
Center Classification Date20210421
Recall Initiation Date20210331
Recalling FirmSmiths Medical ASD Inc.
Initial Notification E-Mail
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