Health product recall

5mm ENDOPATH XCEL Bladeless Trocars with Stability Sleeve and 5mm ENDOPATH XCEL with OPTIVIEW Technology Universal Trocar Stability Sleeve (2018-03-26)

Starting date:
March 26, 2018
Posting date:
May 1, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66606

Affected products

A. 5MM ENDOPATH XCEL BLADELESS TROCARS WITH STABILITY SLEEVE

B. 5MM ENDOPATH XCEL WITH OPTIVIEW TECHNOLOGY UNIVERSAL TROCAR STABILITY SLEEVE

Reason

Recently, Ethicon has become aware of reports from customers related to difficulty removing the obturator from the 5mm ENDOPATH XCEL Trocars with OPTIVIEW technology. For that reason, a voluntary recall is being issued of specific products with expiration dates between September 2022 through January of 2023.

Affected products

A. 5MM ENDOPATH XCEL BLADELESS TROCARS WITH STABILITY SLEEVE

 

Lot or serial number

Lots with Expiration Date Range: 2022-09-30 to 2023-01-31

Model or catalog number

2B5LT

2B5ST

2B5XT

Companies
Manufacturer

ETHICON ENDO-SURGERY, LLC.

475 CALLE C

GUAYNABO

00969

PUERTO RICO


B. 5MM ENDOPATH XCEL WITH OPTIVIEW TECHNOLOGY UNIVERSAL TROCAR STABILITY SLEEVE

Lot or serial number

Lots with Expiration Date Range: 2022-09-30 to 2023-01-31

Model or catalog number

2CB5LT

2CB5ST

Companies
Manufacturer

ETHICON ENDO-SURGERY, LLC.

475 CALLE C

GUAYNABO

00969

PUERTO RICO