Z-0817-2018Class II

Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS...

Name: Z-0817-2018 Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS...
Creator: Circulatory Technology Inc
Published: 2017-09-22
License: https://open.fda.gov/license/

Circulatory Technology, Inc. / initiated 2017-09-22 / Terminated / root cause: manufacturing process

FDA source

Circulatory Technology Inc began a recall of Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers) on 2017-09-22. FDA classified it as Class II and gives the reason as "The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit...". 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-0817-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-22
Posted: 2018-03-01
Terminated: 2020-05-20
Recalling firm: Circulatory Technology, Inc.
Product: Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Product code: DTN Reservoir, Blood, Cardiopulmonary Bypass
Reason for recall: The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm is requesting that consignees immediately inspect inventory, and quarantine all units having the aforementioned lots. These units must be returned to CTI. CTI will provide UPS shipping labels for returning the units and will provide replacements or credit for the returned units. Should the inventory consist of only the affected lots then, until the consignee receives replacement BB14s from an unaffected lot, the firm recommends using the BB14 from the affected lots only if, prior to its use, they pull on the pigtail of the Better-Bladder to test its bond integrity prior to its use. If the pigtail dislodges then return the unit for credit or replacement. The consignees should complete and return the enclosed response form via email to [email protected] as soon as possible.
Quantity in commerce: 840
Distribution: **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
Product codes and lots: **Recall expanded to add additional lot numbers highlighted with "**": BB14 Lot Numbers: 5290-S19785, 5290-S19786, 5290-S19872, **5290-S19925; BB14NS Lot Numbers: 17062201, 17062202, 17062203, and **170905

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0817-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0817-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-23
Z-1171-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-23

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)