Medtronic Cardiovascular Revascularization & Surgical Therap Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
Brand
Medtronic Cardiovascular Revascularization & Surgical Therap
Lot Codes / Batch Numbers
Lot 10279571, Use By 2012-01-31
Products Sold
Lot 10279571, Use By 2012-01-31
Medtronic Cardiovascular Revascularization & Surgical Therap is recalling Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits due to Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MN
Page updated: Jan 10, 2026