Administration Set with 1, 2, 3 Connectors, Standard Bore Extension Set with Bonded MaxPlus Connector, Minibore Extension Set, MaxPlus Positive Pressure Needleless IV Connector (2019-04-23)
- Starting date:
- April 23, 2019
- Posting date:
- May 10, 2019
- 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-69890
Last updated: 2019-05-10
Affected Products
- Administration Set with 2 Connectors
- Administration Set with 1 Connector
- Administration Set with 3 Connectors
- Standard Bore Extension Set with Bonded MaxPlus Connector
- Minibore Extension Set
Reason
There is a potential for fluid to escape upon disconnection of a male luer from the BD MaxZero connector. To mitigate the occurrence, BD is updating the instructions for use (IFU) with recommendation related to disconnecting from the BD MaxZero connector.
Affected products
A. Administration Set with 2 Connectors
Lot or serial number
All lots.
Model or catalog number
- MZ5313
- MZ5316
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
B. Administration Set with 1 Connector
Lot or serial number
All lots.
Model or catalog number
- MZ5312
- MZ8002
- MZ8003
- MZT1003
- MZT1004
- MZX5301
- MZX5302
- MZXT5303
- MZXT5307
- MZXT9004
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
C. Administration Set with 3 Connectors
Lot or serial number
All lots.
Model or catalog number
- MZ8001
- MZ9313
- MZXT9003
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
D. Standard Bore Extension Set with Bonded MaxPlus Connector
Lot or serial number
All lots.
Model or catalog number
- MZ5303
- MZ5304
- MZ5305
- MZ5308
- MZ5309
- MZ5310
- MZ9280
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
E. Minibore Extension Set
Lot or serial number
All lots.
Model or catalog number
- MZ5301
- MZ5302
- MZ5306
- MZ5307
- MZ9226
- MZ9265
- MZ9266
- MZ9267
- MZ9270
- MZ9271
- MZ9272
- MZ9273
- MZ9274
- MZ9275
- MZ9276
- MZ9277
- MZ9278
- MZ9279
- MZ9281
- MZ9283
- MZXT9001
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
F. MaxPlus Positive Pressure Needleless IV Connector
Lot or serial number
All lots.
Model or catalog number
- MZ1000-07
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND