Recall Z-1885-2018— Ethicon Endo-Surgery Inc

Name: FDA recall Z-1885-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-26

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2018-03-26, terminated 2020-04-08. It names one FDA 510(k) clearance: K032676. Product: 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT. Reason: 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..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2018-03-26
Terminated: 2020-04-08
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K032676 — ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAREthicon Endo-Surgery, Inc.·cleared 2003-10-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.