CLASS II Device recall · Reported 20 Apr 2022 · FDA Enforcement Report
Claravue Pre-wired Electrode Ip-set N3 - Pediatric-us recalled
Graphic Controls Acquisition is recalling Claravue Pre-wired Electrode Ip-set N3 - Pediatric-us, distributed nationwide in the US. The recall was initiated on 15 Mar 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0935-2022
- FDA event ID
- 89810
- Recalling firm
- Graphic Controls Acquisition, Buffalo, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2022
- FDA classified
- 14 Apr 2022
- Reported
- 20 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Mar 2022 | Recall initiated by company | |
| 14 Apr 2022 | Classified by FDA | +30 days |
| 20 Apr 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
Where it was distributed
US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
Nationwide ArkansasCaliforniaColoradoFloridaIndianaKansasMassachusettsMinnesotaNew YorkOklahomaVermont
Questions about this recall
Is Claravue Pre-wired Electrode Ip-set N3 - Pediatric-us recalled?
Yes. Graphic Controls Acquisition recalled Claravue Pre-wired Electrode Ip-set N3 - Pediatric-us on 15 Mar 2022. The recall is Class II and its status is Terminated. Recall number Z-0935-2022.
Why was it recalled?
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Which lots are affected?
All lots UDI: 03700506307357
Where was it sold?
US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Graphic Controls Acquisition
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Claravue Pre-wired Electrode - IP Set 6V RT Adult-us recalled | Graphic Controls Acquisition | Device Malfunction | Nationwide |
| Device | CLASS II | Claravue Pre-wired Electrode - IP Set M5 RT Adult-us recalled | Graphic Controls Acquisition | Device Malfunction | Nationwide |
| Device | CLASS II | Claravue Pre-wired Electrode - IP Set 5V RT Adult recalled | Graphic Controls Acquisition | Device Malfunction | Nationwide |
| Device | CLASS II | Claravue Pre-wired Electrode - IP Set 12 RT Adult-us recalled | Graphic Controls Acquisition | Device Malfunction | Nationwide |
| Device | CLASS II | Claravue Pre-wired Electrode - IP Set M3 RT Adult-us recalled | Graphic Controls Acquisition | Device Malfunction | Nationwide |
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