Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in t
FDA device recall Z-2152-2012 · posted 2012-08-07 · Terminated
Recall details
- Recalling firm
- Impact Instrumentation, Inc.
- Reason for recall
- Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
- Action taken
- Impact Instrumentation Inc. notified their sole customer via email on 3/15/12 and then emailed an "Urgent Device Product Recall" letter and tracking form dated 3/19/2012. The letter described the reason for the recall and provided recommended actions and the contact number for Customer Service.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- Ten Units
- Distribution
- US Distribution to the state of Illinois.
- Date initiated
- 2012-03-19
- Date posted
- 2012-08-07
- Date terminated
- 2012-08-15
- 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 |
|---|---|---|
| UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR (K103318) | Impact Instrumentation, Inc. | 2011-04-07 |