Reported Jun 29, 2022 · Terminated
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of…
Getinge USA Sales Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Getinge Usa Sales Inc · 1 Geoffrey Way · Wayne, NJ · 07470-2035
Is this the product you have?
- Flow-e Anesthesia SystemIntended for use in administering anesthesia while controlling the entire ventilation
- of patient Product Code/REF Number6887900
- Lot codes and dates
- UDI-DI07325710010457
- Serial Numbers
50012500135001450015500165001750030500315003350034500355003650037500385003950040500415004250043500465004750048500515005250053500545005550056500575005850059500605006150062500695007050071500725007350074500845008550086500875008850089500905009150092500935009450096500975010850109501105011150132. (Note: UDI was corrected July 72022)
- Amount recalled
- 47 units US
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Using this product could cause serious injury, illness or death — stop using it now.
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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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