Recall Z-1023-2016— Medtronic Perfusion Systems
Class III · Terminated
Class III FDA medical device recall by Medtronic Perfusion Systems, initiated 2016-02-04, terminated 2016-11-07. It names 3 FDA 510(k) clearances: K012538, K924529, K891687. Product: Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Reason: Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-02-04
- Terminated
- 2016-11-07
- Firm location
- Brooklyn Park, MN, United States
510(k) clearances named in this recall
3 on FDA's record- K012538 — TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
- K924529 — SIGNATURE(TM) CUSTOM TUBING PACK
- K891687 — EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures
Reason for recall
Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.
Data sourced from openFDA. This site is unofficial and independent of the FDA.