Recall Z-0152-2022— Smiths Medical ASD Inc.

Name: FDA recall Z-0152-2022
Creator: U.S. Food and Drug Administration
Published: 2020-12-08

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2020-12-08, terminated 2023-08-04. It names one FDA 510(k) clearance: K172410. Product: smiths medical portex Loss of Resistance Device, REF 100/398/000. Reason: The labeling was missing information on sterilization and prohibition of reuse..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-08
Terminated: 2023-08-04
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K172410 — Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio FiltersSmiths Medical Asd, Inc.·cleared 2018-06-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

smiths medical portex Loss of Resistance Device, REF 100/398/000

Reason for recall

The labeling was missing information on sterilization and prohibition of reuse.

Data sourced from openFDA. This site is unofficial and independent of the FDA.