Recall Z-2430-2012— Impact Instrumentation, Inc.

Name: FDA recall Z-2430-2012
Creator: U.S. Food and Drug Administration
Published: 2012-03-30

Class III · Terminated

Class III FDA medical device recall by Impact Instrumentation, Inc., initiated 2012-03-30, terminated 2015-07-21. It names one FDA 510(k) clearance: K820331. Product: Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.. Reason: A shipment mix-up took place..

Recalling firm: Impact Instrumentation, Inc.
Classification: Class III
Status: Terminated
Initiated: 2012-03-30
Terminated: 2015-07-21
Firm location: West Caldwell, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K820331 — IMPACT, MODEL 302Impact Instrumentation, Inc.·cleared 1982-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.

Reason for recall

A shipment mix-up took place.

Data sourced from openFDA. This site is unofficial and independent of the FDA.