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Terminated

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

FDA Recall Z-0152-2022 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeBSP
Date Initiated2020-12-08
Date Terminated2023-08-04
Product Quantity3420 devices

Reason for Recall

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

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172410Portex 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. · 2018-06-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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