Recall Z-1479-2021 ยท DRS Transducer, Blood-Pressure, Extravascular
Smiths Medical ASD Inc.
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
| Date | Apr 21, 2021 (initiated Mar 31, 2021) |
| Status | Terminated |
| Reason | 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 | Process control |
| 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 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 possess |
| Quantity | 8150 units |
| Distribution | Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.