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U.S. Department of Health and Human Services

Class 2 Device Recall STORZ High Flow Insufflation Tubing (with filter)

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  Class 2 Device Recall STORZ High Flow Insufflation Tubing (with filter) see related information
Date Initiated by Firm October 10, 2017
Create Date November 16, 2017
Recall Status1 Terminated 3 on June 22, 2018
Recall Number Z-0098-2018
Recall Event ID 78289
Product Classification Tubing/tubing with filter, insufflation, laparoscopic - Product Code NKC
Product STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.
Code Information Lot #129241
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information Contact Susie S. Chen
424-218-8201
Manufacturer Reason
for Recall		 The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
FDA Determined
Cause 2		 Labeling mix-ups
Action The recalling firm issued letters flagged as 'SAFETY ALERT" dated 10/5/2017 via Federal Express on 10/10/2017.
Quantity in Commerce 496/10-pouch boxes
Distribution Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
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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