Physio-Control QuikCombo Pacing and Defibrillation Electrodes Recalled for Wire Insulation Damage
Covidien is recalling 56,000 sets of Physio-Control QuikCombo electrodes due to potential wire insulation damage that could cause burns or reduced therapy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of burns to patients and clinicians, which aligns with the rubric criteria for a Severe rating involving significant injury reports or high-risk medical device defects.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 56,000 sets of Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes Redi-Pak Preconnect Systems, Item Code PM20022. The recall was initiated by the manufacturer, Covidien LLC, due to a potential defect in the wire insulation.
The identified hazard is that damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy, as well as patient and/or clinician burns. The affected lots are 516907, 519815, and 519816.
The product was distributed nationwide and in Canada, Australia, Denmark, Germany, and New Zealand. Users should stop using the affected product and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
- Manufacturer
- Covidien LLC
- Affected units
- 56,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: 516907
- 519815
- 519816
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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