medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841.
This recall has been terminated (originally issued August 17, 2010).
- Recall Initiated
- July 2, 2010
- Posted
- August 17, 2010
- Terminated
- October 13, 2010
- Recall Number
- Z-2235-2010
- Quantity
- 47 units
- Firm Location
- Harleysville, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.
Distribution
Worldwide Distribution -- USA, including states of NC and TX and country of Israel.
Lot / Code Info
Lot #MAZL630, Exp. 04/2015
Root Cause
Employee error
Action Taken
Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp.
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