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U.S. Department of Health and Human Services

Class 2 Device Recall ACCELERATOR APS System

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 Class 2 Device Recall ACCELERATOR APS Systemsee related information
Date Initiated by FirmMay 15, 2007
Date PostedJuly 03, 2007
Recall Status1 Terminated 3 on November 27, 2007
Recall NumberZ-1041-2007
Recall Event ID 37969
Product Classification Centrifuge - Product Code JQP
ProductACCELERATOR 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
ActionFirm 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 Commerce1 unit.
DistributionDevice distributed to a hospital in UT.
Total Product Life CycleTPLC 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.
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