Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
FDA Recall Z-1424-2009 · Posted 2009-06-23
Advertisement
Recall StatusTerminated
Product CodeDWE
Date Initiated2009-02-25
Date Terminated2011-05-07
Product Quantity20 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Distribution to one medical facility in MN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement