Recall Z-2430-2012 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Impact Instrumentation, Inc.
Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
| Date | Sep 20, 2012 (initiated Mar 30, 2012) |
| Status | Terminated |
| Reason | A shipment mix-up took place. |
| 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: aglordano@impactii.com. |
| Quantity | 2 devices |
| Distribution | Nationwide distribution: USA including states of: FL and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820331 | IMPACT, MODEL 302 Impact Instrumentation, Inc., Feb 23, 1982 |