CLASS II Device recall · Reported 5 Jun 2019 · FDA Enforcement Report
Maquet Getinge-Beq-top 15705 Material recalled by Maquet Cardiovascular
Maquet Cardiovascular is recalling Maquet Getinge-Beq-top 15705 Material: 701051122, distributed nationwide in the US. The recall was initiated on 18 Apr 2019 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-1514-2019
- FDA event ID
- 82703
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Apr 2019
- FDA classified
- 30 May 2019
- Reported
- 5 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 18 Apr 2019 | Recall initiated by company | |
| 30 May 2019 | Classified by FDA | +42 days |
| 5 Jun 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Maquet Getinge-BEQ-TOP 15705 Material: 701051122
Where it was distributed
Nationwide
Questions about this recall
Is Maquet Getinge-Beq-top 15705 Material: 701051122 recalled?
Yes. Maquet Cardiovascular recalled Maquet Getinge-Beq-top 15705 Material: 701051122 on 18 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1514-2019.
Why was it recalled?
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Which lots are affected?
Batch Numbers: 3000044566 3000046394 3000049202 3000054550 3000058043 3000060239 3000066276 3000069368 3000071833 3000074339 3000080701 3000081598
Where was it sold?
Nationwide
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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