Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
Recall
- Recall Number
- Z-1480-2021
- Event Number
- 87647
- Firm
- Smiths Medical ASD Inc.
- FEI Number
- 3012307300
- Product Code
- DRS
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 31, 2021
- Posted
- April 21, 2021
- Terminated
- March 20, 2023
- Address
- 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
Description
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
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.
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.
Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
11340 units