Z-0152-2022Class II

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

Name: Z-0152-2022 smiths medical portex Loss of Resistance Device, REF 100/398/000
Creator: Smiths Medical ASD Inc.
Published: 2020-12-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-12-08 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of smiths medical portex Loss of Resistance Device, REF 100/398/000 on 2020-12-08. FDA classified it as Class II and gives the reason as "The labeling was missing information on sterilization and prohibition of reuse". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0152-2022
Classification: Class II
Status: Terminated
Initiated: 2020-12-08
Posted: 2021-10-19
Terminated: 2023-08-04
Recalling firm: Abbott Medical
Product: smiths medical portex Loss of Resistance Device, REF 100/398/000
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Reason for recall: The labeling was missing information on sterilization and prohibition of reuse.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0152-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0152-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-19

Product code BSP

K172410Class IIPortex 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)