Date Initiated by Firm |
May 15, 2007 |
Date Posted |
July 03, 2007 |
Recall Status1 |
Terminated 3 on November 27, 2007 |
Recall Number |
Z-1041-2007 |
Recall Event ID |
37969 |
Product Classification |
Centrifuge - Product Code JQP
|
Product |
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy. |
Code Information |
LN 7L01-01. |
Recalling Firm/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Drive PO Box 152020 Irving TX 75038
|
Manufacturer Reason for Recall |
Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator.
|
FDA Determined Cause 2 |
Other |
Action |
Firm notified consignee via letter on 05/15/07. Consignee informed of potential for injury and advised that a label would be affixed to the device lid by an Abbott representative. |
Quantity in Commerce |
1 unit. |
Distribution |
Device distributed to a hospital in UT. |
Total Product Life Cycle |
TPLC Device Report
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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.
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