Salle Intraoperative Pyeloplasty Stent Sets, LSE Kwart Retro-Inject Stent Set - Ureteral (2019-04-21)

Starting date:

April 21, 2019

Posting date:

May 17, 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-69948

Last updated: 2019-05-17

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  Reason
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  Affected products

Affected Products

A. Salle Intraoperative Pyeloplasty Stent Sets

B. LSE Kwart Retro-Inject Stent Set - Ureteral

Reason

A field safety notice is being launched to ensure affected customers are aware of an issue involving the instructions for use (IFU) for the Kwart Retro-Inject Stent Set and Salle Intraoperative Pyeloplasty Stent Set. The IFUs are being updated to include a warning statement about the potential for stent knotting to occur with the use of the affected devices and its possible outcomes.

Affected products