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U.S. Department of Health and Human Services

Class 3 Device Recall Insufflation tubing set, with gas filter

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  Class 3 Device Recall Insufflation tubing set, with gas filter see related information
Date Initiated by Firm January 09, 2019
Create Date May 09, 2020
Recall Status1 Terminated 3 on September 28, 2022
Recall Number Z-1942-2020
Recall Event ID 85388
Product Classification Tubing/tubing with filter, insufflation, laparoscopic - Product Code NKC
Product Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Code Information Model/Lot Number:  031200-10/Lot W-027781, W-029058, W-028738; 031322-10/ Lot W-027197, W-028171, W-027939, W-028207; 031532-10/ Lot W-026437, W-027332, W-026871; 031622-10/Lot W-029555 
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
Manufacturer Reason
for Recall		 The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
FDA Determined
Cause 2		 Vendor change control
Action The recalling firm sent an URGENT SAFETY NOTICE OF PRODUCT RECALL (via FedEx) to the impacted customers on 01/09/20120, along with acknowledgement confirmation for customer to sign and return it to the firm.
Quantity in Commerce 543 boxes were distributed; 10 ea per box.
Distribution 57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI
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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