5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
- Company
- Ethicon Endo-Surgery Inc
- Recall Initiated
- March 26, 2018
- Terminated
- April 8, 2020
- Recall Number
- Z-1885-2018
- Quantity
- 118352
- Firm Location
- Blue Ash, OH
Reason for Recall
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Distribution
Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
Lot / Code Info
Lots P4T58Y P4T59E P4T627 P4T665 P4T66C P4T716 P4T71L P4T780 P4T83K P4T844 P4T87R P4T88E P4T88G P4T88H P4T927 P4T942 P4T946 P4T94D P4TA19 P4TA3V P4TA4N P4TA4R P4TA9K P4TA9R P4TC2E P4TC2T P4TC67 P4TC6Z P4TD1M R4000W R40045 R4004G R4007H R4013R R40172 R4017C R4021R R4021U R4023D R40267 R4026E R4031V R4036K R4036V R40397 R4041C R4041J R4044A R4044K R4048E
Root Cause
Process control
Action Taken
The firm notified customers and distributors by letter on March 26, 2018, and March 27, 2018, respectively. Customers were informed of the issue and potential risk of prolonged surgery or introduction of minute particles. Customers were instructed to: 1. Examine your inventory immediately to determine if you have any products subject to this recall on hand and quarantine such product(s). 2. Remove the products subject to this recall from your inventory and communicate the issue to all relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any of the devices subject to this recall have been forwarded to another facility, please contact that facility to arrange return. 3. Complete the Business Reply Form confirming receipt of this notice and fax or email it to Stericycle at 1-888-965-5794 or Ethicon3546@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lot subject to this recall. 4. Customers are required to return all unused devices subject to this recall that are in their inventory immediately. 5. To return unused devices subject to this recall photocopy the completed BRF, place it in the box with the subject product(s), and affix the pre-paid authorized shipping label included with this recall notification letter. Distributors were instructed to: 1. Examine your inventory immediately to determine if you have the product lot subject to this recall on hand and quarantine such product(s). 2. Remove the product lot subject to this recall and communicate the issue to all relevant materials management personnel, or anyone else in your facility who needs to be informed. 3. Complete the Business Reply Form confirming receipt of this notice and fax or email it to Stericycle at 1-888-965-5794 or Ethicon3546@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lot subject to this rec