LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.

FDA device recall Z-1473-2021 · posted 2021-04-21 · Terminated

Recall details

Recalling firm

Smiths Medical ASD Inc.

Reason for recall

Specific 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.

Action taken

The firm initiated the action by email on 03/31/2021. The Recall Notice instructs consignees to identify, and quarantine affected product in their possession. A list of affected product has been included on the Recall Notice for consignees to identify affected product. The consignees have been instructed to complete the response form, and return it to fieldactions@smiths-medical.com within 10 days of receipt. After the completed Recall Response Form has been submitted to fieldactions@smiths-medical.com, the consignee will be contacted to arrange return of any affected product in their possession. Distributors have been instructed that if they have distributed potentially affected product to their customers to immediately notify them of the Recall.

Root cause

Process control

Status

Terminated

Product code

DRS

Quantity affected

3740 devices

Distribution

Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

Date initiated

2021-03-31

Date posted

2021-04-21

Date terminated

2023-03-20

Location

Minneapolis, MN

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