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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis Radial Source Spring Wire Transradial Access Kit Product

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 Class 2 Recall
Cordis Radial Source Spring Wire Transradial Access Kit Product
see related information
Date Posted June 27, 2013
Recall Status1 Terminated on August 04, 2014
Recall Number Z-1608-2013
Recall Event ID 65464
Premarket Notification
510(K) Number
Product Classification Introducer, Catheter - Product Code DYB
Product Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.
Code Information Manufacturing Lot : W18499722
Recalling Firm/
Greatbatch Medical
2300 Berkshire Ln N
Minneapolis, Minnesota 55441-4575
Manufacturer Reason
for Recall
Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire.
FDA Determined
Cause 2
Action Greatbatch Medical and Cordis sent an "Urgent Field Safety Notice" dated May 31, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were instructed: 1.Read the Description of the problem section. 2. Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. 3. Review, complete, sign and return the enclosed Acknowledgement Form in accordance with the directions on the form. 4. Either return any affected product per the attached instruction, or contact your local sales representative to facilitate return of the affected product. Credit will be provided. 5. Pass on this notice to anyone in your facility that needs to be informed. 6. If any product listed above has been forwarded to another facility, contact that facility to arrange return. 7. Maintain awareness of this notice until all product listed above has been removed from the facility and returned to Cordis. 8. Maintain a copy of this notice with affected product until product is returned. We apologize for any inconvenience this communication may cause. We know that you place high value in our products and we appreciate your cooperation in this matter. Cordis and Greatbatch are committed to maintaining your confidence in the safety and quality of the products that Greatbatch manufactures and Cordis supplies. Further questions please call (763) 951-8181.
Quantity in Commerce 550 kits (OUS)
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Greatbatch Medical