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U.S. Department of Health and Human Services

Class 2 Device Recall Transfer Spike (Blood processing accessory)

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  Class 2 Device Recall Transfer Spike (Blood processing accessory) see related information
Date Initiated by Firm February 25, 2009
Date Posted June 23, 2009
Recall Status1 Terminated 3 on May 07, 2011
Recall Number Z-1424-2009
Recall Event ID 51952
510(K)Number K800178  
Product Classification Blood processing accessory - Product Code DWE
Product Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
Code Information Lot 10279571, Use By 2012-01-31 
Recalling Firm/
Manufacturer		 Medtronic Cardiovascular Revascularization & Surgical Therap
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact
763-391-9000
Manufacturer Reason
for Recall		 Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.
FDA Determined
Cause 2		 Device Design
Action Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" letter dated March 5, 2009. The letter was addressed to Risk Manager. The letter described the product and problem and requested the consignee to complete, sign and return the certificate acknowledgement.
Quantity in Commerce 20 units
Distribution Distribution to one medical facility in MN.
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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