Recall Z-1772-2013— Ethicon Endo-Surgery Inc

Name: FDA recall Z-1772-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-08

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2013-04-08, terminated 2013-12-24. It names one FDA 510(k) clearance: K912492. Product: Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.. Reason: The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-08
Terminated: 2013-12-24
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K912492 — EVACUATION/IRRIGATION/ELECROSURGICAL DEVICEETHICON, Inc.·cleared 1991-10-21

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

Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.

Reason for recall

The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.

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