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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium

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  Class 2 Device Recall Atrium see related information
Date Initiated by Firm May 12, 2008
Date Posted August 14, 2008
Recall Status1 Terminated 3 on August 20, 2009
Recall Number Z-1832-2008
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 # 9020,
Size (Fr) 20,
# Eyelets 4,
10 per case
Code Information Lot #s 10321934,10336528,10337106 
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 34 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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