Z-1371-2011

Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor, MI. The Adult...

Name: Z-1371-2011 Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor, MI. The Adult...
Creator: Heart Sync, Inc
Published: 2010-12-17
License: https://open.fda.gov/license/

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies / initiated 2010-12-17 / Terminated / root cause: packaging

FDA source

Heart Sync, Inc began a recall of Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor, MI. The Adult Radiolucent Multifunction Tin Electrodes are indicated... on 2010-12-17. The reason FDA records is "The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1371-2011
Status: Terminated
Initiated: 2010-12-17
Posted: 2011-02-18
Terminated: 2011-07-13
Recalling firm: Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
Product: Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor, MI. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.
Product code: MLN Electrode, Electrocardiograph, Multi-Function
Reason for recall: The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes. and Electrodes may dry out when removed from packaging and exposed to air.
Root cause tag: packaging
FDA root cause: Packaging
Action: Heart Sync, Inc sent an URGENT MEDICAL DEVICE RECALL letter dated December 23, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Examine their inventory and quarantine product that was subject to the recall that was not sealed properly. Contact any customers if they further distributed the product and notify them at once of this product recall. Contact the firm if they had any unused product. The firm would issue a UPS Call Tag to have the product returned to them and the firm would send replacement product as soon as they were notified. Complete and return the Recall Return Response Form to the firm in the attached prepaid envelope. For any questions regarding this recall call 734-213-5530.
Quantity in commerce: 300
Distribution: Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada
Product codes and lots: Lot Y-032709

Product code MLN

K080421Class IIIHeart Sync, Models C-100 and T-100Heart Sync, LLC / cleared 2008-02-29

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)