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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic Intersept Custom Tubing Pack

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  Class 3 Device Recall Medtronic Intersept Custom Tubing Pack see related information
Date Initiated by Firm September 13, 2006
Date Posted January 25, 2007
Recall Status1 Terminated 3 on February 03, 2007
Recall Number Z-0340-2007
Recall Event ID 36333
510(K)Number K800178  
Product Classification Custom Tubing Pack - Product Code DWE
Product Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine. Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Tube supplier: Natvar (Tekni-Plex Co.), 19555 E. Arenth Ave., City of Industry, CA 91748.
Code Information The following Model / Lot Number are affected: CB4W39R1 / 4876667; 0A84R2 / 4531036; 1708R18 / 4627100; 0V68R4 / 4212182; 1P07R6 / 4433014; 1P07R6 / 4678134; 2Y91R / 4628170; 2Y91R / 4800224; 2Y91R / 4902036; CB0Q49R14 / 4800849; 4D87R2 / 4184927.
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Rick Leonard
763-391-9167
Manufacturer Reason
for Recall		 An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.
FDA Determined
Cause 2		 Other
Action An Important Customer Notification, dated 09/06/06, was sent to affected customers. The letter identifies the affected model and lot numbers. Medtronic requests that affected product be returned. A suplemental pack can be built and shipped to the customer upon request. Medtronic will replace all returned product. A Recall Certificate is asked to be completed by customer and faxed to Medtronic.
Quantity in Commerce 146
Distribution Distributed in 6 states: CA, FL, IL, IN, LA and TN
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 = DWE and Original Applicant = EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
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