Z-2234-2009

S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525...

Name: Z-2234-2009 S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525...
Creator: Leonhard Lang Gmbh
Published: 2009-07-10
License: https://open.fda.gov/license/

Leonhard Lang GmbH / initiated 2009-07-10 / Terminated / root cause: manufacturing process

FDA source

Leonhard Lang Gmbh began a recall of S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525 Flight Path Drive Brooksville, Florida 34604 The... on 2009-07-10. The reason FDA records is "A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2234-2009
Status: Terminated
Initiated: 2009-07-10
Posted: 2009-09-24
Terminated: 2011-12-17
Recalling firm: Leonhard Lang GmbH
Product: S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525 Flight Path Drive Brooksville, Florida 34604 The device is non-sterile and single use. For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. In such cases increased force or some wiggling is required to insert the connector fully. A potential risk for patients exist, if (a) such a connector (b)
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A Leonhard Lang letter dated June 9, 2009 was sent June 6, 2009 to its customer. The letter identified the problem and the product. The letter instructed the consignee to stop using or distributing the product and to quarantine them. It also requested them to report all quantities of product that they had in stock using the attached form.
Quantity in commerce: 3044
Distribution: Worldwide Distribution - US - FL Foreign: Austria, Germany, Romania, France, Dubai, Greece, Italy, South Korea, United Kingdom, Hungary, Latvia, Saudi Arabia and Lebanon
Product codes and lots: DF-20 S&W Lot #'s 80505-0778, 80814-0773, 80930-0775, 81017-0777, 90226-0776, 90403-0779, 90420-0775

Product code MKJ

K072233Class IIISkintact Multifunctional Electrodes with Dh02 Gel with Different Connectors Compatible with Different DefibrillatorsLeonhard Lang GmbH / cleared 2007-10-05

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)