Z-2430-2012Class III

Model 324JL On-Board Suction System

Name: Z-2430-2012 Model 324JL On-Board Suction System
Creator: Impact Instrumentation, Inc.
Published: 2012-03-30
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2012-03-30 / Terminated / root cause: manufacturing process

FDA source

Impact Instrumentation, Inc. began a recall of Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers on 2012-03-30. FDA classified it as Class III and gives the reason as "A shipment mix-up took place". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2430-2012
Classification: Class III
Status: Terminated
Initiated: 2012-03-30
Posted: 2012-09-20
Terminated: 2015-07-21
Recalling firm: ZOLL Medical Corporation
Product: Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Reason for recall: A shipment mix-up took place.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Impact Instrumentation Inc., contacted their customers via phone and email notification on April 9, 2012. Customers were provided the correct packing slip and asked to acknowledge the correction. If you have any questions, contact the Regulatory Affairs Manager at 973-882-1212 or email: [email protected].
Quantity in commerce: 2 devices
Distribution: Nationwide distribution: USA including states of: FL and OH.
Product codes and lots: Model 324JL S/N 120142 and S/N 120144

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2430-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2430-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code JCX

K820331Class IIImpact, Model 302Impact Instrumentation, Inc. / cleared 1982-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)