Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
This recall has been terminated (originally issued June 23, 2009).
- Recall Initiated
- February 25, 2009
- Posted
- June 23, 2009
- Terminated
- May 7, 2011
- Recall Number
- Z-1424-2009
- Quantity
- 20 units
- Firm Location
- Brooklyn Park, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Distribution to one medical facility in MN.
Lot / Code Info
Lot 10279571, Use By 2012-01-31
Root Cause
Device Design
Action Taken
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.