Recall Z-2430-2012
Impact Instrumentation, Inc. · initiated March 30, 2012
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
Codes / lots: Model 324JL S/N 120142 and S/N 120144
Reason for recall
A shipment mix-up took place.
FDA-determined cause: Process control
Action taken
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: aglordano@impactii.com.
Details
- Recall number
- Z-2430-2012
- Initiated
- March 30, 2012
- Posted by FDA
- September 20, 2012
- Terminated
- July 21, 2015
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Quantity
- 2 devices
- Distribution
- Nationwide distribution: USA including states of: FL and OH.
- Recalling firm
- Impact Instrumentation, Inc., West Caldwell, NJ