24CM DECATHLON MINI KIT Model: DM19SH24 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling stylet, (2) injection sealing caps, and warning label. Latex free.
Recall
- Recall Number
- Z-0303-2010
- Event Number
- 53605
- Firm
- Spire Biomedical, Inc. One Patriots Park
- FEI Number
- 1000159376
- Product Code
- MSD
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 23, 2009
- Posted
- November 17, 2009
- Terminated
- June 9, 2010
- Address
- Bedford, MA, 01730-2343
Description
24CM DECATHLON MINI KIT Model: DM19SH24 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling stylet, (2) injection sealing caps, and warning label. Latex free.
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
81 units