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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 Recall
Transfer Spike (Blood processing accessory)
see related information
Date Posted June 23, 2009
Recall Status1 Open
Recall Number Z-1424-2009
Recall Event ID 51952
Premarket Notification
510(K) Number
K800178 
Product Classification Tubing, Pump, Cardiopulmonary Bypass - 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, Minnesota 55428-1088
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
DESIGN: 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 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 = DWE and Original Applicant = EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
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