Health product recall

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

  1. Administration Set with 2 Connectors
  2. Administration Set with 1 Connector
  3. Administration Set with 3 Connectors
  4. Standard Bore Extension Set with Bonded MaxPlus Connector
  5. 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