FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
- Recall number
- Z-2104-2014
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
- Status
- Terminated
- Initiated
- 2014-05-23
- Posted
- 2014-07-23
- Terminated
- 2015-02-24
- Reason
- During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
- Root cause
- Process control
- Action
- Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.
- Quantity
- 2,290 units
- Distribution
- Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.
- Lot, serial or model codes
- 28 Fr with 3/8" flare , Part No., 816460, Lot #:, 0645280, 0649157, 0654734, 0666686, 0674810, 0678724, 0682221, 0684790, 0698319, 0698910; 30 Fr with 3/8" connector , Part No., 820732, Lot #:, 646450 & 30 Fr with 3/8" flare , Part No., 820731, Lot #:, 0689843, 0698323
- 510(k) numbers
- ["K080034"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28