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Medstorm Adult Radiolucent Electrode Philips Medical… recallZ-1371-2011 · Heart Sync, Inc · initiated Dec 17, 2010

Terminated All recalls posted in February 2011

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 Heart Sync, Inc 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

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.

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-1371-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 17, 2010
Posted by the FDA
Feb 18, 2011
Recalling firm
Heart Sync, Inc
Quantity
300
Product code
MLN
FDA submissions
K080421
Distribution
Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada

Product description

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.

Code information (models, lots, serial numbers)

Lot Y-032709

Other devices under the same FDA submission

4 devices cleared under K080421 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 57736).

Sources and updates

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