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Terminated

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.

FDA Recall Z-1845-2020 · Posted None

Recalling FirmTeDan Surgical Innovations LLC
Recall StatusTerminated
Product CodeGEA
Date Initiated2019-07-16
Date Terminated2021-09-14
Product Quantity2 units

Reason for Recall

There was incorrect raw material used in the production of the identified lot.

Firm 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: [email protected] or at 713-726-0886.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US Nationwide distribution in the states of NJ.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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