CLASS III Device recall · Reported 26 Sep 2012 · FDA Enforcement Report
Model 324JL On-Board Suction System Intended use: On-board suction recalled
Impact Instrumentation is recalling Model 324JL On-Board Suction System Intended use: On-board suction, distributed nationwide in the US. The recall was initiated on 30 Mar 2012 and the FDA has classified it as Class III.
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-2430-2012
- FDA event ID
- 62736
- Recalling firm
- Impact Instrumentation, West Caldwell, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Mar 2012
- FDA classified
- 20 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 30 Mar 2012 | Recall initiated by company | |
| 20 Sep 2012 | Classified by FDA | +174 days |
| 26 Sep 2012 | 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
A shipment mix-up took place.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
Where it was distributed
Nationwide distribution: USA including states of: FL and OH.
Questions about this recall
Is Model 324JL On-Board Suction System Intended use: On-board suction recalled?
Yes. Impact Instrumentation recalled Model 324JL On-Board Suction System Intended use: On-board suction on 30 Mar 2012. The recall is Class III and its status is Terminated. Recall number Z-2430-2012.
Why was it recalled?
A shipment mix-up took place.
Which lots are affected?
Model 324JL S/N 120142 and S/N 120144
Where was it sold?
Nationwide distribution: USA including states of: FL and OH.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Impact Instrumentation
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|---|---|---|---|---|---|
| Device | CLASS III | Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield recalled | Impact Instrumentation | Device Malfunction | IL |
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