Z-1886-2012Class II

X-Coated Fx25rw H/l Pack

Name: Z-1886-2012 X-Coated Fx25rw H/l Pack
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-05-09
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-05-09 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to... on 2012-05-09. FDA classified it as Class II and gives the reason as "During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS'...". 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-1886-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-09
Posted: 2012-06-27
Terminated: 2013-04-24
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Terumo sent an Urgent Medical Device Recall letter dated May 9, 2012 to All US first consignees will receive a removal notification letter via Federal Express. The letter identified the affected products, reason for correction and actions to be taken. Customers were instructed to discontinue use of affected products and return for replacement. The letter advised customers to assure that all users are aware of this notice and to fill out and return the attached Response Form. For questions call Terumo CVS Customer Service at 1-800-521-2818 or by fax at 1-800-292-6551.
Quantity in commerce: 53,139 (each) in total
Distribution: Worldwide Distribution - US (nationwide) including the states of: AL, AR , AZ , CA, CT , FL, IA , IL, IN , KS , LA , MI , NM, MO , NC, NE , NJ , NV, NY , OH, OK , PA, RI , SC , TN, TX, WA , WI, WV and the countries of: BELGIUM, BRAZIL, Byelorussian SSR, CAMBODIA , Dominican Republic, Honduras, Japan, Malaysia, Mexico, Nicaragua, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, UNITED ARAB EMIRATES (UAE), and Vietnam.
Product codes and lots: Catalog number: 74301 and lot number: PD19

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1886-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1875-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1876-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1877-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1878-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1879-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1880-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1881-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1882-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1883-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1884-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1885-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1886-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1887-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1888-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1889-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1890-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1891-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1892-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1893-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27
Z-1894-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27

Product code DWF

K873212Class IISarns Cardioplegia/vent Catheters3M Health Care, Sarns / cleared 1987-11-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)