Health product recall

Alaris Pump Administration Sets (2018-04-17)

Starting date:
April 17, 2018
Posting date:
May 11, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66746

Affected products

  1. INFUSION SET - SS MF LOW SORBING
  2. INFUSION SET - LOW SORB CV SS
  3. INFUSION SET - NV SS CHECK VALVE
  4. INFUSION SET - LOW SORB NV CV SS BAG ACCESS PORT
  5. INFUSION SET - CV SS
  6. INFUSION SET - DP CKV SS DEHP FREE
  7. INFUSION SET - V/NV SMS DP
  8. INFUSION SET - V/NV SS DP
  9. INFUSION SET - V/NV CV SS DEHP FREE
  10. INFUSION SET - V/NV CKV SMS DP
  11. INFUSION SET - V/NV CKV SS DP
  12. INFUSION SET - V/NV CKV MF SMS
  13. INFUSION SET - V/NV MC SS DP DEHP
  14. INFUSION SET - SMARTSITE

Reason

The Alaris Infusion Pump Administration Sets require priming prior to patient use as described in the directions for use.  It is during the priming process that this issue can be observed.  During priming, when attempting to fill the drip chamber, the drops into the drip chamber will not be observed once the roller clamp is opened. This issue is highly detectable.

Affected products

A. INFUSION SET - SS MF LOW SORBING

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

11532269

Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


B. INFUSION SET - LOW SORB CV SS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

10013072

Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


C. INFUSION SET - NV SS CHECK VALVE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 10013361
  • 10013361T
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


D. INFUSION SET - LOW SORB NV CV SS BAG ACCESS PORT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

10015861A

Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


E. INFUSION SET - CV SS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 10013186
  • 11404930
  • 11590100
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


F. INFUSION SET - DP CKV SS DEHP FREE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

10817613

Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


G. INFUSION SET - V/NV SMS DP

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2421-0500

Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


H. INFUSION SET - V/NV SS DP

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

11287205

Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


I. INFUSION SET - V/NV CV SS DEHP FREE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2420-0007

Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


J. INFUSION SET - V/NV CKV SMS DP

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2420-0500

Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


K. INFUSION SET - V/NV CKV SS DP

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 2426-0007
  • 2426-0500
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


L. INFUSION SET - V/NV CKV MF SMS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 2430-0500
  • 2432-0007
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


M. INFUSION SET - V/NV MC SS DP DEHP

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 10010541
  • 10010541-07
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND


N. INFUSION SET - SMARTSITE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2452-0007

Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND