Z-2106-2014Class II

CPB Catheter Kit

Name: Z-2106-2014 CPB Catheter Kit
Creator: Terumo Cardiovascular Systems Corporation
Published: 2014-05-23
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2014-05-23 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the... on 2014-05-23. FDA classified it as Class II and gives the reason as "During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2106-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-23
Posted: 2014-07-23
Terminated: 2015-02-24
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 125 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.
Product codes and lots: Part No. 80003-02, Lot #: PG11, QC11, QL09 & Part No. 80002-03, Lot #: PG11, QL09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2106-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2094-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2095-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2096-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2097-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2098-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2099-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2100-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2101-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2102-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2103-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2104-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2105-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22
Z-2106-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22

Product code DWF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)