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INFUSION SETS (2015-05-20)
- Starting date:
- May 20, 2015
- 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-54214
Affected Products
- Paradigm Sure-T Infusion Set
- Contact Detach Infusion Set
- Thalaset G29 Infusion Sets
- Thalaset G27 Infusion Sets
- Neria Subcutaneous Infusion Sets
- Neria Detach
- Neria Detach Needle
- Neria Multi
Reason
Manufacturer has identified that in rare cases the steel needle can break during use. The malfunction broken needle could result in a reduction of medication administration. In addition, the broken needle may require surgical removal.
Affected products
A.Paradigm Sure-T Infusion Set
Lot or serial number
All lots, contact Mfg
Model or catalog number
MMT-862
MMT-864
MMT-874
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3
Osted
B.Contact Detach Infusion Set
Lot or serial number
All lots, contact Mfg
Model or catalog number
100-905-00
100-905-01
100-905-02
100-905-03
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3
Osted
C.Thalaset G29 Infusion Sets
Lot or serial number
All lots, contact Mfg
Model or catalog number
71-110-2931
71-110-2936
71-110-2938
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3
Osted
D.Thalaset G27 Infusion Sets
Lot or serial number
All lots, contact Mfg
Model or catalog number
71-060-2736
71-060-2738
71-080-2736
71-080-2738
71-110-2731
71-110-2736
71-XXX-2731
71-XXX-2736
71-XXX-2738
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3
Osted
E. Subcutaneous Infusion Sets
Lot or serial number
All lots, contact Mfg
Model or catalog number
78-060-2731
78-060-2736
78-060-2738
78-060-2931
78-060-2936
78-060-2938
78-080-2731
78-080-2736
78-080-2738
78-080-2931
78-080-2936
78-080-2938
78-110-2731
78-110-2736
78-110-2738
78-110-2931
78-110-2936
78-110-2938
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3
Osted
F.Neria Detach
Lot or serial number
All lots, contact Mfg
Model or catalog number
78-060-2721
78-060-2726
78-060-2728
78-080-2721
78-080-2726
78-080-2728
78-110-2721
78-110-2726
78-110-2728
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3
Osted
G.Neria Detach Needle
Lot or serial number
All lots, contact Mfg
Model or catalog number
75-000-2721
75-000-2726
75-000-2728
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3
Osted
H.Neria Multi
Lot or serial number
All lots, contact Mfg
Model or catalog number
721060-2731
721060-2738
721060-3731
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3
Osted