Z-2050-2016Class II

Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

Name: Z-2050-2016 Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Creator: Circulatory Technology Inc
Published: 2016-03-03
License: https://open.fda.gov/license/

Circulatory Technology, Inc. / initiated 2016-03-03 / Terminated / root cause: design

FDA source

Circulatory Technology Inc began a recall of Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 on 2016-03-03. FDA classified it as Class II and gives the reason as "The seal between the balloon and the housing may leak". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2050-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-03
Posted: 2016-06-27
Terminated: 2017-04-20
Recalling firm: Circulatory Technology, Inc.
Product: Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Product code: DTN Reservoir, Blood, Cardiopulmonary Bypass
Reason for recall: The seal between the balloon and the housing may leak.
Root cause tag: design
FDA root cause: Device Design
Action: Circulatory Technology Inc. sent an Urgent Product Recall notices dated March 3, 2016, to their customers via email. Circulatory Technology Inc. has identified this action as a voluntary recall, however they did not withdraw the product from the market. Instead, Circulatory Technology Inc. has advised customers to check the integrity of the seal between both the inlet and outlet tube and the housing as per the Instructions For Use. In addition, for this lot, Circulatory Technology Inc. recommends that you bend the inlet as well as the outlet tube away from the housing before conducting the leak test. There should be no visible separation between the tubing and the housing. Customers with questions can call 516-624-2424.
Quantity in commerce: 72 units
Distribution: US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
Product codes and lots: Lot # 014603 USE BY: 9/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2050-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2050-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-27

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)