Reported Sep 7, 2016 · Terminated

Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This…

Terumo Cardiovascular Systems Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Terumo Cardiovascular Systems Corp · 28 Howe St · Ashland, MA · 01721-1305

Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled
containing Coated Tubing as followsThis 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
124 of 124 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

Lot codes and dates: US Lot CodesUG06 UE18R UF31 UF31A UF31T UG13 UG13A
UG20 UG20T UG27 UG27T OUS Lot CodesUG13 UG13T UG20 UG20T
Amount recalled: 2207 kits

Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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7 in total.