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
Affected Products
- Namic Stopcock
- 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
-
Namic Stopcock
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 70015002
- 70015012
- 70015015
- 70035008
- 70055003
- 70055009
- 70055017
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
B. Namic Manifold
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 70037200
- 70038202
- 70038303
- 70039303
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES