Electrosurgical Tip Cleaner; PL recallZ-0149-2020 · Xodus Medical Inc · initiated Sep 19, 2019

Why it was recalled

The sterile barrier of some devices may have been affected

FDA root cause category: Packaging

What the company is doing

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 [email protected] 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; [email protected] 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

Recall details

Recall number

Z-0149-2020

Status

Terminated

Initiated by the company

Sep 19, 2019

Posted by the FDA

Oct 16, 2019

Recalling firm

Xodus Medical Inc

Quantity

464,040 eaches

Product code

GEI

FDA submissions

K053433

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

Product description

Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Electrosurgical Tip Cleaner; PL 138029

  Xodus Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 recall2 reports

Product lines

• Electrosurgical Tip Cleaner; PLXodus Medical, Inc. · 2 models · 2 reports · 2 recalls

Other devices under the same FDA submission

1 device cleared under K053433 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• 30500 Cautery Tip Cleaner

  Xodus Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 83819).

• Z-0150-2020 · Terminated
  Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
• Z-0151-2020 · Terminated
  Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory