Recall Z-1845-2020
TeDan Surgical Innovations LLC · initiated July 16, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot: 0619
Reason for recall
There was incorrect raw material used in the production of the identified lot.
FDA-determined cause: Mixed-up of materials/components
Action taken
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: dfishman@tedansurgical.com or at 713-726-0886.
Details
- Recall number
- Z-1845-2020
- Initiated
- July 16, 2019
- Terminated
- September 14, 2021
- Product code
- GEA – Cannula, Surgical, General & Plastic Surgery
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of NJ.
- Recalling firm
- TeDan Surgical Innovations LLC, Sugar Land, TX