Sprotte Regional Needle (2019-08-30)

Starting date:

August 30, 2019

Posting date:

October 3, 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-71121

Last updated: 2019-10-03

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  Reason
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  Affected products

Affected Products

Sprotte Regional Needle

Reason

Pajunk received a customer complaint related to a medical product delivered as sterile with defective sterile barrier system (pinhole in SBS).

This defect may cause cannulas to be non-sterile at the time of use on the patient. After a detailed examination of retention patterns of different manufacturing batches it can not be excluded that products packed with the same tool do not have the same defect. Based on the information currently available the defect can be linked to a specific tool used for the packaging of certain products.

Affected products