Recalls / —
—#186776
Product
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
- FDA product code
- DRS — Transducer, Blood-Pressure, Extravascular
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- Lot Number 3946994
Why it was recalled
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.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
Timeline
- Recall initiated
- 2021-03-31
- Posted by FDA
- 2021-04-21
- Terminated
- 2023-03-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #186776. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.