—#136456

Product

Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.

FDA product code: DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K820297
Affected lot / code info: Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03

Why it was recalled

The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.

Root cause (FDA determination)

Component design/selection

Action the firm took

Consignees were notified of the recall by phone beginning on 5/7/2015 and a Urgent Medical Device Recall letter, dated 5/7/2015. The letter identified the affected device, reason for recall, potential hazard, and correction. Customers were asked to review the notice and ensure that all users are aware of the issue. In addition, they are to confirm the quantity of procedure kits for return; and, complete and return the Customer Response Form. Customers can call Terumo CVS Customer Service at 1-800-521-2818 with questions.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

Distribution pattern: Distributed to the states of MO and FL.

Timeline

Recall initiated: 2015-05-06
Posted by FDA: 2015-06-23
Terminated: 2015-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.