CUSTOM PACK WITH SOFTLINE (2021-03-23)

Starting date:

March 23, 2021

Posting date:

April 1, 2021

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-75297

Last updated:
2021-04-01

• 
  Reason
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  Affected products

Affected Products

CUSTOM PACK WITH SOFTLINE

Reason

The sterile pouch (component #700007026) is used to pack the accessories that are placed inside the primary sterile barrier (blister) and intended to organize the articles inside the primary packaging. The pouch #700007026 is used for packing the centrifugal pump ""rotaflow"" and the manifold line,

which are not pre-connected to the tubing set.

The ability of the sterile pouch to maintain its integrity as a sterile barrier during storage and transport is insufficiently demonstrated. The sterility of the device itself is however not affected as the integrity of the primary sterile barrier (blister) is not compromised by storage and transport conditions.

Affected products