Z-0057-2017Class III

The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the...

Name: Z-0057-2017 The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the...
Creator: Circulatory Technology Inc
Published: 2016-07-01
License: https://open.fda.gov/license/

Circulatory Technology, Inc. / initiated 2016-07-01 / Terminated

FDA source

Circulatory Technology Inc began a recall of The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous... on 2016-07-01. FDA classified it as Class III and gives the reason as "Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0057-2017
Classification: Class III
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-10-07
Terminated: 2017-04-14
Recalling firm: Circulatory Technology, Inc.
Product: The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Product code: DTN Reservoir, Blood, Cardiopulmonary Bypass
Reason for recall: Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
FDA root cause: Use error
Action: The firm, Circulatory Technology Inc., sent an "Urgent: Device Recall" letter dated July 1, 2016 and response forms to their customers via email. The letter described the product, problem and actions to be taken. The letter instructed customers to immediately inspect their inventory visually for units with wrinkled or twisted balloons and quarantine. Customers were also advised to complete and return the response form via email to [email protected]. Customers with questions are asked to contact Yehuda Tamari at (516) 624-2424, Monday to Friday, 9:00 AM - 7:00 PM, EST.
Quantity in commerce: 958 units
Distribution: US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
Product codes and lots: Lot Numbers: R19229, 015323, 014882, 014602 & 014601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0057-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0057-2017	Class III	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-07

Product code DTN

K981284Class IIBetter-Bladder (Bb)Circulatory Technology, Inc. / cleared 1998-08-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)