FDA Device recall Z-2706-2016
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for…
- FDA Device
- Class II
- terminated
- Published 2016-09-07
On 2016-09-07 the FDA classified a Class II recall of Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for… by Terumo Cardiovascular Systems, citing terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2706-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-25 |
| Published | 2016-09-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
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 which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit. US Product Codes: 72021 72358 71180-01 76021 76022 76023 76024 76025 71801-01 71801-01 71801-01 71801-01 71801-01 74163-03 71296-01 74460-01 74460-01 74460-01 73208-03 74382-01 74382-01 74382-01 74916 74916 74916 70089-07 74063-01 74063-01 74460-01 74460-01 74460-01 74460-01 75252-01 74951 75881 74271-01 71085-02 72742 75314 75368 75368 76095 76095 73339-01 73789 74417 72204 72965-03 73644 73645-01 73700 73861 73871 73901-03 75612 75617 75986 76095 73645-01 73645-01 70099-04 75544 75272 75674 75674 73180 73180 73180 75437 75674 75274 73811 73811 74915 71175-03 73738 76117 75129 75642 75642 72596 72596 72596 75179 74980-01 8340TXC-07 8340TXC-07 8340TXC-07 71875-01 74235-01 74476 75059 75547 75547 74235-01 8351TXC-01 73124 73281-01 73282-01 73874 74477 8340TXC-07 76069 76070 76071 76072 74737 73933 73933 73933 73933 73933 73933 71608-04 75413 74959 75472 75472 75449 75923 75923 73729-01 73730-01 74046-
Reason
Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated
Identifiers
| code_info | US Lot Codes: UG06 UE18R UF31 UF31A…US Lot Codes: UG06 UE18R UF31 UF31A UF31T UG13 UG13A UG20 UG20T UG27 UG27T OUS Lot Codes: UG13 UG13T UG20 UG20T |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2706-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.