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CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK… recallZ-0720-2020 · Abbott Medical · initiated Nov 11, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.

FDA root cause category: Process control

What the company is doing

The firm initiated the recall by hand delivered letter on 11/11/2019. The letter explained the issue and requested the return of the recalled product.

Recall details

Recall number
Z-0720-2020
Status
Terminated
Initiated by the company
Nov 11, 2019
Recalling firm
Abbott Medical
Quantity
470 devices
Product code
GXI
FDA submissions
K090955
Distribution
Worldwide distribution - US Nationwide and country of Bermuda.

Product description

CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

Code information (models, lots, serial numbers)

UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K090955 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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