Z-2832-2016Class II

The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates...

Name: Z-2832-2016 The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates...
Creator: Circulatory Technology Inc
Published: 2016-07-01
License: https://open.fda.gov/license/

Circulatory Technology, Inc. / initiated 2016-07-01 / Terminated / root cause: design

FDA source

Circulatory Technology Inc began a recall of The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when... on 2016-07-01. 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-2832-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-09-15
Terminated: 2018-06-14
Recalling firm: Circulatory Technology, Inc.
Product: The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures 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: The seal between the balloon and the housing may leak.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Circulatory Technology Inc., sent an amended "Urgent: Expanded Device Recall" letter dated July 1, 2016, and response form to their customers via email. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect their inventory, quarantine and prepare to ship the product back to Circulatory Technology Inc. Customers were also instructed to complete and return the response form via email to [email protected]. Customers with questions can call 516-624-2424, Monday through Friday 9:00 AM - 7:00 PM, EST.
Quantity in commerce: 20 units
Distribution: US Distribution to states of: LA, MI, NY, OH, OR & TX.
Product codes and lots: Lot # 014648 USE BY: 09/01/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2832-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2832-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15

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)