Date Initiated by Firm | October 23, 2009 |
Date Posted | November 17, 2009 |
Recall Status1 |
Terminated 3 on June 09, 2010 |
Recall Number | Z-0335-2010 |
Recall Event ID |
53605 |
510(K)Number | K032061 K040509 K042858 K060155 K063431 K063441 |
Product Classification |
Blood access device and accessories - Product Code MSD
|
Product | 55CM ALTA LR GOLD STD KIT
Model: ALC50SH55
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr
dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. |
Code Information |
Al lot codes |
Recalling Firm/ Manufacturer |
Spire Biomedical, Inc. One Patriots Park Bedford MA 01730-2343
|
For Additional Information Contact | Edward Rule 617-275-6000 Ext. 274 |
Manufacturer 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 |
FDA Determined Cause 2 | Process control |
Action | 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. |
Quantity in Commerce | 136 units |
Distribution | Worldwide distribution - Nationwide, Government. Foreign: Canada, France. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = MSD 510(K)s with Product Code = MSD
|