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U.S. Department of Health and Human Services

Class 2 Device Recall Fukushima suction tubes

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  Class 2 Device Recall Fukushima suction tubes see related information
Date Initiated by Firm July 16, 2019
Create Date May 01, 2020
Recall Status1 Terminated 3 on September 14, 2021
Recall Number Z-1845-2020
Recall Event ID 85360
Product Classification Cannula, surgical, general & plastic surgery - Product Code GEA
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.
Code Information Lot: 0619
Recalling Firm/
Manufacturer		 TeDan Surgical Innovations LLC
12615 W Airport Blvd Ste 200
Sugar Land TX 77478-6203
For Additional Information Contact Danny Fishman
713-726-0886
Manufacturer Reason
for Recall		 There was incorrect raw material used in the production of the identified lot.
FDA Determined
Cause 2		 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 in Commerce 2 units
Distribution US Nationwide distribution in the states of NJ.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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