Reported May 13, 2020 · Terminated
Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima…
TeDan Surgical Innovations LLC
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: TeDan Surgical Innovations LLC · 12615 W Airport Blvd Ste 200 · Sugar Land, TX · 77478-6203
Is this the product you have?
- Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM
- REFTK-1110 -
- Product UsageTSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field
- Lot codes and dates
- Lot0619
- Amount recalled
- 2 units
Where it was sold
- Nationwide
- NJ
Why it was recalled
There was incorrect raw material used in the production of the identified lot.
This product could cause temporary or reversible health problems — stop using it.
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