General/Major GYN/Minor GYN Laparoscopy CDS Pack (2016-07-07)

Starting date:

July 7, 2016

Posting date:

July 22, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-59488

• Reason
• Affected products

Affected products

1. MINOR GYN LAPAROSCOPY CDS PACK


2. GENERAL LAPAROSCOPY CDS PACK
3. MAJOR GYN LAPAROSCOPY CDS PACK

Reason

Medline has received a recall notice from ConMed regarding their Core Reposable Trumpet Hand Piece (Conmed p/n cd8300). These hand pieces are used as a component in several CDS modules sold by Medline Canada. ConMed is issuing this recall because the individual package seal may be compromised which could potentially affect the integrity of the sterile barrier. The hand pieces are to be removed from the packs upon opening and discarded. The Medline pack has been terminally sterilized, therefore the remaining components within the pack are safe to use.

Affected products