Recall Z-1474-2021 ยท FPB Filter, Infusion Line
Smiths Medical ASD Inc.
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
| 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 | 400 devices |
| 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
| K961404 | MX960 REUSABLE PRESSURE TRANSDUCER Medex, Inc., Jun 27, 1996 |