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Paradigm Sure-T, Silhouette, Comfort Short, Comfort Kit, Contact Detach, Accu-Check Tender I and II Infusion Sets (2014-11-03)
- Starting date:
- November 3, 2014
- Posting date:
- November 27, 2014
- 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-42183
Recalled Products
A) Paradigm Sure-T Infusion Set
B) Silhouette Infusion Sets
C) Paradigm Silhouette Infusion Sets
D) Comfort Short Infusion Sets
E) Comfort Kit Infusion Sets
F) Contact Detach Infusion Sets
G) Accu-Check Tender I Infusion Set
H) Accu-Check Tender II Infusion Set
Reason
Manufacturer has identified an increase in reports of the tubing becoming detached at the connect/disconnect location. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify patients. The interruption of insulin delivery can cause hyperglycemia, which if left untreated, can result in diabetic ketoacidosis (DKA). DKA is a serious condition that can cause a severe impact to health, including death. Symptoms of DKA may include nausea, vomiting, shortness of breath and excess thirst/urination. Manufacturer is advising patients to seek medical attention immediately if they are experiencing any of these symptoms.
Affected products
A) Paradigm Sure-T Infusion Set
Lot or serial number
All lots,contact manufacturer.
Model or catalog number
MMT-862
MMT-864
MMT-874
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3,
Osted, Lejre,
4320
DENMARK
B) Silhouette Infusion Sets
Lot or serial number
All lots,contact manufacturer.
Model or catalog number
MMT-371
MMT-373
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3,
Osted, Lejre,
4320
DENMARK
C) Paradigm Silhouette Infusion Sets
Lot or serial number
All lots,contact manufacturer.
Model or catalog number
MMT-368600
MMT-377600
MMT-378600
MMT-381600
MMT-383600
MMT-384600
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3,
Osted, Lejre,
4320
DENMARK
D) Comfort Short Infusion Sets
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10024001
10024003
10024004
10024005
89-060-2522
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3,
Osted, Lejre,
4320
DENMARK
E) Comfort Kit Infusion Sets
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10000600
10000601
10000602
10000603
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3,
Osted, Lejre,
4320
DENMARK
F) Contact Detach Infusion Sets
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10090500
10090501
10090502
10090503
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3,
Osted, Lejre,
4320
DENMARK
G) Accu-Check Tender I Infusion Set
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04541413001
04541430001
04541448001
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3,
Osted, Lejre,
4320
DENMARK
H) Accu-check Tender II Infusion Set
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04541464001
04541502001
Companies
- Manufacturer
-
Unomedical A/S
Aaholmvej 1-3,
Osted, Lejre,
4320
DENMARK