Home / Recalls / TeDan Surgical Innovations LLC / Z-1845-2020

Z-1845-2020 Class II Terminated

Recalled by TeDan Surgical Innovations LLC — Sugar Land, TX

Recall Details

Product Type
Devices
Report Date
May 13, 2020
Initiation Date
July 16, 2019
Termination Date
September 14, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

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.

Distribution Pattern

US Nationwide distribution in the states of NJ.

Code Information

Lot: 0619

Other recalls by TeDan Surgical Innovations LLC

  • Z-2528-2020 Class II — PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: (May 15, 2020)
  • Z-2527-2020 Class II — PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended t (May 15, 2020)
  • Z-2524-2020 Class II — 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be us (May 15, 2020)
  • Z-2525-2020 Class II — 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be us (May 15, 2020)
  • Z-2526-2020 Class II — PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended t (May 15, 2020)
  • Z-2529-2020 Class II — PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: (May 15, 2020)
  • Z-2530-2020 Class II — PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage (May 15, 2020)
  • Z-1504-2020 Class II — D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Di (February 18, 2019)
  • Z-1505-2020 Class II — DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These (February 18, 2019)
  • Z-1506-2020 Class II — DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These (February 18, 2019)