Recall Z-1845-2020— TeDan Surgical Innovations LLC
Class II · Terminated
Class II FDA medical device recall by TeDan Surgical Innovations LLC, initiated 2019-07-16, terminated 2021-09-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI 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.. Reason: There was incorrect raw material used in the production of the identified lot..
- Recalling firm
- TeDan Surgical Innovations LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-16
- Terminated
- 2021-09-14
- Firm location
- Sugar Land, TX, United States
Product description
Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI 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.
Reason for recall
There was incorrect raw material used in the production of the identified lot.
Data sourced from openFDA. This site is unofficial and independent of the FDA.