CLASS II Device recall · Reported 30 Jul 2014 · FDA Enforcement Report
Sarns Two-stage Venous Return Cannulae 32/40 recalled
Terumo Cardiovascular Systems is recalling Sarns Two-stage Venous Return Cannulae 32/40 & 36/ with 1/2" & 3/8" flare or connector, distributed nationwide in the US. The recall was initiated on 23 May 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2100-2014
- FDA event ID
- 68404
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2014
- FDA classified
- 22 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 23 May 2014 | Recall initiated by company | |
| 22 Jul 2014 | Classified by FDA | +60 days |
| 30 Jul 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Stores named: CVS
Questions about this recall
Is Sarns Two-stage Venous Return Cannulae 32/40 & 36/ with 1/2" & 3/8" flare or connector recalled?
Yes. Terumo Cardiovascular Systems recalled Sarns Two-stage Venous Return Cannulae 32/40 & 36/ with 1/2" & 3/8" flare or connector on 23 May 2014. The recall is Class II and its status is Terminated. Recall number Z-2100-2014.
Why was it recalled?
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Which lots are affected?
Part No. 4442, Lot #:, 0646528, 0649147, 0649840, 0654076, 0662223, 0678729; Part No. 14992, Lot #: 0646475, 0649160, 0655317, 0659466, 0666649, 0672081, 0675675, 0681806, 0686885; Part No. 4443, Lot #: 0649883, 0660672 & Part No. 15949, Lot #: 0646530, 0661896, 0667259, 0674784, 0683631.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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