FDA Recall
Terminated
UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
Recall: Z-0159-04
·
Initiated November 5, 2003
Recall
- Recall Number
- Z-0159-04
- Event Number
- 27749
- Firm
- Merit Medical Systems, Inc
- FEI Number
- 1721504
- Product Code
- DQO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 5, 2003
- Posted
- November 27, 2003
- Terminated
- December 1, 2003
- Address
- 1600 Merit Pkwy South, Jordan, UT, 84095-2416
Description
UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
Reason
Angiographic catheter tips may separate during use.
Action
All 7 consignees were contacted by their sales representatives on 11/5-7/2003.
Distribution
FL, MI, NY, PA, TN, TX. No foreign, government, or military distribution.
Quantity
32 units