Date Initiated by Firm |
March 19, 2012 |
Date Posted |
August 07, 2012 |
Recall Status1 |
Terminated 3 on August 15, 2012 |
Recall Number |
Z-2152-2012 |
Recall Event ID |
62535 |
510(K)Number |
K103318
|
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
|
Product |
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation. |
Code Information |
Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297. |
Recalling Firm/ Manufacturer |
Impact Instrumentation, Inc. 23 Fairfield Pl West Caldwell NJ 07006-6206
|
For Additional Information Contact |
Mr. Alan Giordiano 973-882-1212
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Process control |
Action |
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. |
Quantity in Commerce |
Ten Units |
Distribution |
US Distribution to the state of Illinois. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = CBK and Original Applicant = IMPACT INSTRUMENTATION, INC.
|