Recall StatusTerminated
Date Initiated2021-03-31
Date Terminated2023-03-20
Product Quantity10 devices
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.
Firm Action
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
[email protected] within 10 days of receipt. After the completed Recall Response Form has been submitted to
[email protected], 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
Distribution Pattern
Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.