Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
FDA device recall Z-1424-2009 · posted 2009-06-23 · Terminated
Recall details
- Recalling firm
- Medtronic Cardiovascular Revascularization & Surgical Therap
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWE
- Quantity affected
- 20 units
- Distribution
- Distribution to one medical facility in MN.
- Date initiated
- 2009-02-25
- Date posted
- 2009-06-23
- Date terminated
- 2011-05-07
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACORP.'S INTERSEPT CUS. TUBING PK. (K800178) | Extracorporeal Medical Specialities, Inc. | 1980-02-21 |