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Terminated

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

FDA Recall Z-2430-2012 · Posted 2012-09-20

Recalling FirmImpact Instrumentation, Inc.
Recall StatusTerminated
Product CodeJCX
Date Initiated2012-03-30
Date Terminated2015-07-21
Product Quantity2 devices

Reason for Recall

A shipment mix-up took place.

Firm 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].

Root Cause

Process control

Distribution Pattern

Nationwide distribution: USA including states of: FL and OH.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K820331IMPACT, MODEL 302Impact Instrumentation, Inc. · 1982-02-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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