28CM ALTA EXCHANGE KIT Model: AL23SH28 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis cathe
FDA device recall Z-0328-2010 · posted 2009-11-17 · Terminated
Recall details
- Recalling firm
- Spire Biomedical, Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 42 units
- Distribution
- Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
- Date initiated
- 2009-10-23
- Date posted
- 2009-11-17
- Date terminated
- 2010-06-09
- Location
- Bedford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 (K063441) | Spire Biomedical, Inc. | 2007-02-12 |
| 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 (K063431) | Spire Biomedical, Inc. | 2007-01-29 |
| 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (K060155) | Spire Biomedical, Inc. | 2006-05-09 |
| 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS (K042858) | Spire Biomedical, Inc. | 2004-12-03 |
| ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 (K040509) | Spire Biomedical, Inc. | 2004-04-19 |
| DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH (K032061) | Spire Biomedical, Inc. | 2003-12-23 |