Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
FDA device recall Z-2430-2012 · posted 2012-09-20 · Terminated
Recall details
- Recalling firm
- Impact Instrumentation, Inc.
- Reason for recall
- A shipment mix-up took place.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JCX
- Quantity affected
- 2 devices
- Distribution
- Nationwide distribution: USA including states of: FL and OH.
- Date initiated
- 2012-03-30
- Date posted
- 2012-09-20
- Date terminated
- 2015-07-21
- Location
- West Caldwell, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPACT, MODEL 302 (K820331) | Impact Instrumentation, Inc. | 1982-02-23 |