Sterile Lap Chole Pack, Gyne Laparoscopy Pack (2019-04-01)

Starting date:

April 1, 2019

Posting date:

April 12, 2019

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-69572

Last updated: 2019-04-12

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  Reason
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  Affected products

Affected Products

1. Sterile Lap Chole Pack
2. Gyne Laparoscopy Pack

Reason

This voluntary recall is being conducted in response to a field corrective action from Stryker, where there is a risk of the tubing detaching from the cassette in their PneumoSure tubesets. This could result in a lack of inflation making it difficult to visualize surgical locations during procedures. The affected surgical kits from Cardinal Presource contain one of the affected Stryker tubesets in their components.

Affected products