Reported Feb 14, 2024 · Ongoing
Bubble Sensor (REF: 70105.5720)
Maquet Medical Systems USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Medical Systems USA · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Bubble Sensor (REF70105.5720)
- Lot codes and dates
- ModelBS 3/8x3/32 L1.7
- Correct UDI DI04037691816432
- Incorrect UDI DI (as labeled)04058863025148
- SNs
70 of 70 codes
900417999004181690041938900420099004206990041802900418179004193990042011900420709004180490041818900419409004203690042071900418059004182190041943900420379004207490041806900418229004195790042038900420769004180790041823900419639004204290042079900418089004182690041966900420499004208390041809900418369004197490042050900420859004181090041898900419839004205490042089900418119004190590041993900420569004209090041812900419079004199490042058900420929004181390041921900419959004206090042093
- Amount recalled
- 274 units (70 US, 204 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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