Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System Item Code:PM20022
FDA device recall Z-2547-2015 · posted 2015-09-02 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns
- Action taken
- Medtonic/Covidien issued recall letter on August 19, 2015. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 2 Ludlow Park Drive, Chicopee, MA 01022, Attention: Field Action Returns. Contact your Medtronic representative or Customer Service at (800)-882-5878.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 56,000 sets
- Distribution
- Nationwide Foreign: Canada Australia Denmark Germany New Zealand
- Date initiated
- 2015-08-19
- Date posted
- 2015-09-02
- Date terminated
- 2017-05-24
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD (K960329) | Contour Medical Technology, Inc. | 1996-07-02 |