StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
This recall has been terminated (originally issued June 12, 2003).
- Company
- Venetec Intl Inc
- Recall Initiated
- May 12, 2003
- Posted
- June 12, 2003
- Terminated
- October 14, 2003
- Recall Number
- Z-0925-03
- Quantity
- 3150 units
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Set tubing disconnected from the male luer lock during use on patients. Misassembled.
Distribution
One distributor sent the product to 6 hospitals in the states of CT, IN, PA, TN.
Lot / Code Info
Lot D207201
Root Cause
Other
Action Taken
A recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product.