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Class 2 Device Recall Electrosurgical Tip Cleaner |
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Date Initiated by Firm |
September 19, 2019 |
Date Posted |
October 16, 2019 |
Recall Status1 |
Terminated 3 on March 04, 2024 |
Recall Number |
Z-0150-2020 |
Recall Event ID |
83819 |
510(K)Number |
K053433
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Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product |
Electrosurgical Tip Cleaner REF: 62-8499-001
Product Usage: electrosurgical accessory |
Code Information |
Lot # 16DEC19
17JAN06
17FEB10
17MAR27
17OCT09
17OCT09A
17OCT23
17OCT23A
18JAN05
18JAN05A
18JAN19
18MAR02
18MAR19
18MAR19A
UDI: Case 20787551000584 and Each - 00787551000580
Additional lots as of 6/8/20:
18APR09
18MAY01
18MAY11
18MAY25
18MAY25A
18MAY25B
18JUN27
18AUG14
18SEP12
18OCT03
Additional lots as of 9/9/2021:
18DEC05
18DEC26
18DEC26A
19JAN30
19JAN30A |
Recalling Firm/ Manufacturer |
Xodus Medical Inc 702 Prominence Dr New Kensington PA 15068-7052
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For Additional Information Contact |
Paul Lloyd 724-337-5500
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Manufacturer Reason for Recall |
The sterile barrier of some devices may have been affected
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FDA Determined Cause 2 |
Packaging |
Action |
Urgent Medical Device Voluntary Recall notification letters dated 9/20/19 were sent to customers. An Urgent Medical Device Voluntary Recall REVISED RECALL NOTICE notification letters were sent to customers on 9/27/19.
1. Immediately check your inventory and quarantine affected stock on hand.
2. The following process shall be undertaken in order to segregate any affected
inventory. The existing inventory shall be inspected and any affected product
quarantined and destroyed.
A. Inspect the Tyvek pouch seal integrity.
B. Secondly, the product contained within the pouch may be partially sealed
into the Tyvek seal itself.
3. unaffected product shall be distributed with no futher action necessary.
4. For any product that is quarantined and must be destroyed:
A. Xodus Medical requires documentation of the affected inventory that is
found to be affected and destroyed. Information regarding the following
shall be documented and provided to Xodus Medical.
B. Product Number; Quantity Affected; Method of Destruction; Evidence of Destruction. It can be photos or videos of product being
destroyed
5. Please immediately complete the attached Acknowledgement form even if you do not have any affected stock, and return the acknowledgement to Xodus
Medical at the following: Email PLloyd@XodusMedical.com or Fax +1 724-337-1131
For further information and question, please call Paul Lloyd, Vice President, Global QA/RA & Technology, Xodus Medical; +1 724-337-5500; PLloyd@XodusMedical.com
Urgent: Medical Device Voluntary Recall REVISED RECALL NOTICE dated 6/8/20 were sent to customers.
Xodus Medical has received complaints of some devices where the sterile barrier of some devices may have been affected. Xodus Medical has confirmed instances where the pouch seal was compromised on some of the reported product. In no instance has it been reported to Xodus Medical that a compromise in the sterile barrier has resul |
Quantity in Commerce |
460,000 eaches |
Distribution |
Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico |
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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510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = XODUS MEDICAL, INC.
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