Namic Stopcock/Manifold (2021-08-18)

Starting date:

August 18, 2021

Posting date:

September 10, 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-76395

Last updated:
2021-09-10

• 
  Reason
• 
  Affected products

Affected Products

1. Namic Stopcock
2. Namic Manifold

Reason

During the testing process, a breach was confirmed in the Sterile barrier via Micro-hole testing, resulting in

the possibility of non-sterile product conditions. The microscopic defects in the Mylar are

6420 70055003 h965700550031

sc 3w hp fm off nb -

pg

0000007025, 0000012635, 0000016518,

5653288, 5658901, 5662967

6420 70055008 h965700550081

sc 3w hp ra/lt off nb

- pg

0000007081, 0000014807, 5653287,

5656299

6420 70055009 h965700550091

sc 3w hp ra off nb -

pg

0000003281, 0000003284, 0000007024,

0000007600, 0000007601, 0000009626,

0000009627, 0000010746, 0000012300,

0000012301, 0000012302, 0000014982,

0000015022, 0000016270, 0000016520,

5653286, 5657315, 5658895, 5658897,

5659900, 5659903, 5659905

6420 70055017 h965700550171

sc 1w hp fm tee nb -

pg

0000007147, 0000010747, 0000015023,

56619973

Medline Canada

5150 Spectrum Way, Suite 300

Mississauga, ON I4W 5G2

Too small to be detected visually with the naked eye, therefore we cannot depend on users to determine whether a unit can be used.

Affected products