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.
Recall
- Recall Number
- Z-1845-2020
- Event Number
- 85360
- Firm
- TeDan Surgical Innovations LLC
- FEI Number
- 3005726885
- Product Code
- GEA
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- July 16, 2019
- Terminated
- September 14, 2021
- Address
- 12615 W Airport Blvd, Ste 200, Sugar Land, TX, 77478-6203
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.
There was incorrect raw material used in the production of the identified lot.
The recalling firm contacted their customer on 7/16/19 by phone. There was a follow up letter, dated 10/2/19 sent to the consignee. The recalling firm instructed their customer to return the recalled product. For questions contact: [email protected] or at 713-726-0886.
US Nationwide distribution in the states of NJ.
2 units