Health product recall

Infusion Sets - SS MF Low Sorbing, Low Sorb CV SS, CV SS, V/NV DP, V/NV CV SS DEHP Free, V/NV CKV SMS DP, V/NV CKV SS DP, Blood Set - NV, SmartSite Needle-Free Valve Port, Filter (2019-04-17)

Starting date:
April 17, 2019
Posting date:
May 16, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69700

Last updated: 2019-05-16

Affected Products

  1. Blood Set - NV, SmartSite Needle-Free Valve Port, Filter
  2. Infusion Set - SS MF Low Sorbing
  3. Infusion Set - Low Sorb CV SS
  4. Infusion Set - CV SS
  5. Infusion Set - V/NV DP
  6. Infusion Set - V/NV CV SS DEHP Free
  7. Infusion Set - V/NV CKV SMS DP
  8. Infusion Set - V/NV CKV SS DP

Reason

Variation in the wall thickness of the administration sets' pumping segment may prevent the upper or lower occluders within the pump module from completely occluding the pump segment after the door is closed and the set's roller clamp is opened. This can result in flow inaccuracies through the pumping cycle process resulting in an over infusion.

Affected products

A. Blood Set - NV, SmartSite Needle-Free Valve Port, Filter

Lot or serial number
  • 18015339
  • 18115199
  • 18115200
  • 18116521
  • 18116637
  • 18116638
  • 18116751
  • 18116752
Model or catalog number
  • 2477-0000
  • 2477-0007
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND

B. Infusion Set - SS MF Low Sorbing

Lot or serial number
  • 17087410
  • 17087411
  • 18096003
  • 18096166
  • 18096167
  • 18096235
  • 18096236
  • 18096294
  • 18096295
  • 18096301
  • 19026173
Model or catalog number
  • 10010453
  • 10010454
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND

C. Infusion Set - Low Sorb CV SS

Lot or serial number
  • 17087329
  • 17087331
  • 18036906
  • 18096654
  • 18115223
Model or catalog number
  • 10015414
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND

D. Infusion Set - CV SS

Lot or serial number
  • 19025787
Model or catalog number
  • 11404930
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND

E. Infusion Set - V/NV DP

Lot or serial number
  • 17087336
Model or catalog number
  • 2200-0500
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND

F. Infusion Set - V/NV CV SS DEHP Free

Lot or serial number
  • 17077398
  • 18015267
  • 18015459
  • 18036965
  • 18075715
  • 18076779
  • 18093077
  • 18115088
  • 18115135
  • 18116500
  • 18116622
  • 18116623
  • 18116624
  • 19013154
  • 19013155
  • 19023000
Model or catalog number
  • 2420-0007
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND

G. Infusion Set - V/NV CKV SMS DP

Lot or serial number
  • 17077358
  • 18093056
  • 18116640
  • 18116641
  • 18116703
Model or catalog number
  • 2420-0500
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND

H. Infusion Set - V/NV CKV SS DP

Lot or serial number
  • 17087341
  • 17125017
  • 18037029
  • 18115003
  • 18115004
  • 18115006
  • 18115007
  • 18115129
  • 18115132
  • 18116575
  • 18116635
  • 18116647
  • 18116648
  • 18116657
  • 18116658
  • 19013152
  • 19013153
  • 19023005
Model or catalog number
  • 2426-0007
  • 2426-0500
Companies
Manufacturer

BD Switzerland SARL

Route de Crassier 17, Business Park Terre Bonne

Eysins

1262

SWITZERLAND