Health product recall

BD Microtrainer: Tubes with K2E (K2EDTA), PST Tubes with LH (Lithium Heparin) - Amber, PST Tube with LH (Lithium Heparin), Z (No Additive Tubes), SST and BD Microtrainer SST - Amber, Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibito...

Starting date:
May 13, 2019
Posting date:
May 31, 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-70069

Last updated: 2019-05-31

Affected Products

  1. BD Microtainer Tubes with K2E (K2EDTA)
  2. BD Microtainer PST Tubes with LH (Lithium Heparin) - Amber
  3. BD Microtainer PST Tubes with LH (Lithium Heparin)
  4. BD Microtainer Z (No Additive Tubes)
  5. BD Microtainer SST and BD Microtainer SST - Amber
  6. BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor

Reason

A damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. Recollecting samples and retesting for the patient may be required if a Microtainer Tube with a damaged reservoir was used. This may lead to a delay in test results being reported and patients being treated. Additionally, a damaged tube reservoir may result in the potential for blood leakage and exposure to healthcare workers.

Affected products

A. BD Microtainer Tubes with K2E (K2EDTA)

Lot or serial number
  • 8101695
  • 8127770
  • 8128575
  • 8129642
  • 8129645
  • 8290928
Model or catalog number

365974

Companies
Manufacturer
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes
07417
New Jersey
UNITED STATES

B. BD Microtainer PST Tubes with LH (Lithium Heparin) - Amber

Lot or serial number
  • 822852N
  • 822853N
  • 822862N
  • 824092N
  • 827652N
  • 827753N
Model or catalog number

365987

Companies
Manufacturer
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes
07417
New Jersey
UNITED STATES

C. BD Microtainer PST Tubes with LH (Lithium Heparin)

Lot or serial number
  • 811071N
  • 815060N
  • 821564N
  • 827699N
Model or catalog number

365985

Companies
Manufacturer
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes
07417
New Jersey
UNITED STATES

D. BD Microtainer Z (No Additive Tubes)

Lot or serial number
  • 8155792
  • 8223778
Model or catalog number

365963

Companies
Manufacturer
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes
07417
New Jersey
UNITED STATES

E. BD Microtainer SST and BD Microtainer SST - Amber

Lot or serial number
  • 8094573
  • 8193507
  • 8207774
  • 8208542
  • 8220937
  • 8236756
  • 8239857
  • 8260948
  • 8262866
  • 8284571
Model or catalog number
  • 365967
  • 365978
Companies
Manufacturer
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes
07417
New Jersey
UNITED STATES

F. BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor

Lot or serial number

8212777

Model or catalog number

365992

Companies
Manufacturer
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes
07417
New Jersey
UNITED STATES