Recall Z-1845-2020 ยท GEA Cannula, Surgical, General & Plastic Surgery
TeDan Surgical Innovations LLC
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.
| Date | Jul 16, 2019 |
| Status | Terminated |
| Reason | There was incorrect raw material used in the production of the identified lot. |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the states of NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.