ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
This recall has been terminated (originally issued July 3, 2007).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- May 15, 2007
- Posted
- July 3, 2007
- Terminated
- November 27, 2007
- Recall Number
- Z-1041-2007
- Quantity
- 1 unit.
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator.
Distribution
Device distributed to a hospital in UT.
Lot / Code Info
LN 7L01-01.
Root Cause
Other
Action Taken
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.
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