CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Beq-top 5210 ECC Set - Respiratory, Custom Tubing Kit recalled
Datascope is recalling Beq-top 5210 ECC Set - Respiratory, 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
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-1709-2018
- 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
- CPAP & Ventilators
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-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
Where it was distributed
Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
AlabamaArkansasCaliforniaDistrict of ColumbiaFloridaIllinoisLouisianaMissouriNorth CarolinaPennsylvaniaSouth CarolinaTexasWashington
Questions about this recall
Is Beq-top 5210 ECC Set - Respiratory, Custom Tubing Kit recalled?
Yes. Datascope recalled Beq-top 5210 ECC Set - Respiratory, Custom Tubing Kit on 19 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-1709-2018.
Why was it recalled?
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.
Which lots are affected?
Lot 3000061303, 3000056130
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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