CLASS II Device recall · Reported 5 Jun 2019 · FDA Enforcement Report
Maquet Getinge-Beq-top 38900 Ecc Pack Material recalled
Maquet Cardiovascular is recalling Maquet Getinge-Beq-top 38900 Ecc Pack Material: 701056368, 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-1547-2019
- 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 38900 ECC PACK Material: 701056368
Where it was distributed
Nationwide
Questions about this recall
Is Maquet Getinge-Beq-top 38900 Ecc Pack Material: 701056368 recalled?
Yes. Maquet Cardiovascular recalled Maquet Getinge-Beq-top 38900 Ecc Pack Material: 701056368 on 18 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1547-2019.
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: 3000041396 3000044053 3000047317 3000050887 3000058131 3000060487 3000060723 3000062458 3000064724 3000071815 3000071817
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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