Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and

FDA device recall Z-1350-2015 · posted 2015-03-28 · Terminated

Recall details

Recalling firm

Leonhard Lang Medizintechnik GmbH

Reason for recall

The electrodes may fail to transmit signals.

Action taken

Consignees were sent via e-mail a Leonhard Lang "Important Safety Notice" letter, dated 24 February 2015. The letter provided the Product trade name, Affected lot numbers, Required Action, Target audience, Details of the affected product which included Description of the problem and Measures to be taken by the user. The letter advised consignees to quarantine the affected product, and to complete and return the acknowledgment form to Leonhard Lang. For questions contact either Sophie Hurmann, Sales Department (tel: +43 512 33425 - 45, fax: +43 512 39 22 10, e-mail: sophia.hurmann@leonhardlang.at) , Stefan Rudig, Quality Department ,(tel: +43 512 33425 -15, fax: +43 512 39 22 10 e-mail: stefan.rudig@leonhardlang.at), or Bernhard Ladner,Qualitats Manager (tel: +43 512 33425- 39, fax: +43 512 39 22 10, e-mail: bernhard.ladner@leonhardlang.at) .

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DRX

Quantity affected

364,800

Distribution

Distributed to FL.

Date initiated

2015-02-24

Date posted

2015-03-28

Date terminated

2017-07-26

Location

Innsbruck, Austria

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