Maquet HLM Tubing Pack; Bioline Coating
This recall has been terminated (originally issued September 12, 2010).
- Company
- Maquet Inc.
- Recall Initiated
- July 13, 2010
- Posted
- September 12, 2010
- Terminated
- August 10, 2011
- Recall Number
- Z-2401-2010
- Quantity
- 5 units
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.
Distribution
Distribution: Pennsylvania
Lot / Code Info
Product number BEQ-TOP 14801; lot numbers 70040244, 70046759.
Root Cause
Process control
Action Taken
Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.
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