Recall Z-0152-2022 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Smiths Medical ASD Inc.
smiths medical portex Loss of Resistance Device, REF 100/398/000
| Date | Dec 8, 2020 |
| Status | Terminated |
| Reason | The labeling was missing information on sterilization and prohibition of reuse. |
| Root cause | Error in labeling |
| Action | The firm notified their consignees of the recall by email on 12/08/2021. Distributors were directed to notify their consignees. The firm is seeking return of the product. |
| Quantity | 3420 devices |
| Distribution | Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex E Smiths Medical Asd, Inc., Jun 1, 2018 |