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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmMay 05, 2004
Date PostedAugust 24, 2005
Recall Status1 Terminated 3 on August 31, 2005
Recall NumberZ-1393-05
Recall Event ID 32288
510(K)NumberK782095 
Product Classification Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
Product''NAMIC Custom Angiographic Kit'' sold under the following labels: (1) Medical University of South Carolina. Pouch Catalog # 60131481; (2) Covenant Medical Center, Pouch Catalog #60131603; (3) St. Joseph Hospital, Pouch Catalog #60101041; (4) Spectrum Health, Pouch Catalog #61020031 (5) Rush Foundation Hospital, Kit #65185472 ****** Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** Each kit is customized to the needs of the particular hospital identified on the product labeling.
Code Information (1) Medical University of SC label: Lot 942414 (2) Covenant label: Lot 939982, 943645;  (3) St. Joseph label: Lot 940424;  (4) Spectrum label: Lot 940054 (5) Rush Foundation label: Lot 945456; 943043
Recalling Firm/
Manufacturer		 Boston Scientific Corp
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information ContactMichael Duerr
518-742-4571
Manufacturer Reason
for Recall		Molded handles used in Angiographic Manifolds may be occluded.
FDA Determined
Cause 2		Other
ActionLetters dated 5/4/2004 to Risk Managers with instructions to return product.
Quantity in Commerce1115 kits
DistributionThe kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTZ
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