CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Beq-t 25502 1/4 Better Bladder , Custom Tubing Kit recalled by Datascope

Datascope is recalling Beq-t 25502 1/4 Better Bladder , Custom Tubing Kit, distributed in 13 states. The recall was initiated on 19 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 3000062029

Quantity recalled40

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-1722-2018
FDA event ID: 79873
Recalling firm: Datascope, Fairfield, NJ
Classification: Class II
Status: Terminated
Recall initiated: 19 Oct 2017
FDA classified: 8 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

19 Oct 2017	Recall initiated by company
8 May 2018	Classified by FDA	+201 days
16 May 2018	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

The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434

Where it was distributed

Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.

Alabama Arkansas California District of Columbia Florida Illinois Louisiana Missouri North Carolina Pennsylvania South Carolina Texas Washington

Questions about this recall

Is Beq-t 25502 1/4 Better Bladder , Custom Tubing Kit recalled?

Yes. Datascope recalled Beq-t 25502 1/4 Better Bladder , Custom Tubing Kit on 19 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-1722-2018.

Why was it recalled?

Which lots are affected?

Lot 3000062029

Where was it sold?

Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.

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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