Date Initiated by Firm |
May 12, 2008 |
Date Posted |
August 14, 2008 |
Recall Status1 |
Terminated 3 on August 20, 2009 |
Recall Number |
Z-1830-2008 |
Recall Event ID |
48124 |
510(K)Number |
K912645
|
Product Classification |
Thoracic Catheter - Product Code GBS
|
Product |
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case |
Code Information |
Lot # 10311107 |
Recalling Firm/ Manufacturer |
Atrium Medical Corporation 5 Wentworth Dr Hudson NH 03051-4929
|
For Additional Information Contact |
Karen Hall 603-880-1433
|
Manufacturer Reason for Recall |
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Atrium Medical issued a press release on 5/12/2008 and notified consignees by facsimile on 5/12/2008. Customers were instructed to contact the firm for a return goods authorization and to notify the firm upon receipt of the recall notice. |
Quantity in Commerce |
10 cases (10 individual/case) |
Distribution |
Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia. |
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 = GBS and Original Applicant = ATRIUM MEDICAL CORP.
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