Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits.
This recall has been terminated (originally issued November 10, 2009).
- Recall Initiated
- September 2, 2009
- Posted
- November 10, 2009
- Terminated
- April 16, 2010
- Recall Number
- Z-0161-2010
- Quantity
- 100 trays
- Firm Location
- Harleysville, PA
- Official Source
- View on FDA website ↗
Reason for Recall
mislabeled as right are actually left
Distribution
Worldwide Distribution -- United States (AR, FL, KS, LA, MO, PA, TN, and TX) and Austria.
Lot / Code Info
Lot Number: MAVV890, exp 2014/07.
Root Cause
Employee error
Action Taken
Medcomp issued a "Product Alert" letter dated September 2, 2009 to all customers informing them of the problem and the need to return the product. For further information, contact Medcomp at 215-256-4201.
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