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
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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
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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 |
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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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