Recall Z-2706-2016 ยท OEZ Cardiovascular Procedure Kit
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner whi
| Date | Jul 25, 2016 |
| Status | Terminated |
| Reason | Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated |
| Root cause | Process control |
| Action | Terumo Cardiovascular Systems issued the Safety Alert dated July 25, 2016 and advises the user that their kit may include uncoated tubing, and further advises the consignee to continue using their kits with consideration of anticoagulation protocols during a procedure. Each consignee is asked to complete a Customer Response Form, and to return the Customer Response Form to Terumo acknowledging their receipt of the form. Consignees can return their affected product for credit/replacement; however, return of the product from the field is a customer option and is not under recommendation from T |
| Quantity | 2207 kits |
| Distribution | Nationwide Foreign: Canada, Latin America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.