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MediChoice
OWENS & MINOR DISTRIBUTION, INC. · Model MC1710H · UDI-DI 10885632116629
MLN
Prescription
0
510(k) clearances
1,348
Adverse events (194 deaths)
9
Recalls
22
Facilities
Description
Electrode Defibrillation Electrocardiogram Radiolucent Vinyl Laminated Foam Conductive Foil Adhesive Hydrogel Pacing Equal To Phillips Dp2 Amp Dp6 Amp M3713A Adult Not Made With Natural Rubber Latex MediChoice
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-03-31 | ConMed Corporation | The specific lot was assembled without the rivet cover. |
| 2010-12-17 | Heart Sync, Inc | 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 i |
| 2010-12-17 | Heart Sync, Inc | 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 i |
| 2008-12-05 | Heart Sync, Inc | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| 2008-12-05 | Heart Sync, Inc | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| 2008-06-16 | Bio-Detek, Inc. | Multi-function electrode programmed as a Pediatric instead of Adult |
| 2007-03-08 | Conmed Corporation | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and |
| 2007-03-08 | Conmed Corporation | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and |
| 2005-11-18 | Philips Medical Systems | The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.