Health product recall

Trima Accel Platelet and Multiplasma Sets (2019-12-19)

Starting date:
December 19, 2019
Posting date:
February 28, 2020
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-72417

Last updated: 2020-03-06

Affected Products

  1. Trima Accel Platelet, Plasma, Auto RBC Set
  2. Trima Accel Platelet + Sampler, Plasma, Auto RBC Set
  3. Trima Accel Auto RBC, Plasma Set
  4. Trima Accel RBC, Plasma Set
  5. Trima Accel RBC, + TLR, Plasma Set
  6. Trima Accel LRS Platelet, Plasma, RBC Set
  7. Trima Accel Enhanced Platelet, Plasma RBC Set
  8. Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set
  9. Trima Accel Platelet Multiplasma, RBC, Autopas Set
  10. Trima Accel Platelet + Sampler, Multiplasma, RBC Set
  11. Trima Accel LRS Platelet, Plasma, Auto RBC Set
  12. Trima Accel LRS Platelet + Sampler, Plasma, Auto RBC Set
  13. Trima Accel LRS Platelet + Auto Pas, Plasma, Auto RBC Set
  14. Trima Accel LRS Platelet + Sampler, Plasma, RBC Set
  15. Trima Accel, Multiplasma Set
  16. Trima Accel LRS Platelet + Sampler, Multiplasma, RBC Set

Reason

Complaints have been received by Terumo BCT for pressure test error alerts that are associated with inflation and pressurization of the sample bag. A new sample bag line clamp was introduced in early 2019 to mitigate the issue. There has been an increase in the frequency of complaints for the issue since the introduction of the new clamp, including one incident in which air was infused into a donor. Root cause investigation identified two potential causes for the failure of the new sidewall clamp.

Affected products

A. Trima Accel Platelet, Plasma, Auto RBC Set

Lot or serial number

All lots.

Model or catalog number
  • 80350
  • 80356
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

B. Trima Accel Platelet + Sampler, Plasma, Auto RBC Set

Lot or serial number

All lots.

Model or catalog number
  • 80360
  • 80366
  • 80470
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

C. Trima Accel Auto RBC, Plasma Set

Lot or serial number

All lots.

Model or catalog number
  • 80520
  • 82520
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

D. Trima Accel RBC, Plasma Set

Lot or serial number

All lots.

Model or catalog number
  • 80500
  • 82500
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

E. Trima Accel RBC, + TLR, Plasma Set

Lot or serial number

All lots.

Model or catalog number

80550

Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

F. Trima Accel LRS Platelet, Plasma, RBC Set

Lot or serial number

All lots.

Model or catalog number
  • 80400
  • 80406
  • 82400
  • 82406
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

G. Trima Accel Enhanced Platelet, Plasma RBC Set

Lot or serial number

All lots.

Model or catalog number
  • 80440
  • 80446
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

H. Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set

Lot or serial number

All lots.

Model or catalog number

80450

Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

I. Trima Accel Platelet Multiplasma, RBC, Autopas Set

Lot or serial number

All lots.

Model or catalog number

80700

Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

J. Trima Accel Platelet + Sampler, Multiplasma, RBC Set

Lot or serial number

All lots.

Model or catalog number

80340

Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

K. Trima Accel LRS Platelet, Plasma, Auto RBC Set

Lot or serial number

All lots.

Model or catalog number
  • 82650
  • 82656
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

L. Trima Accel LRS Platelet + Sampler, Plasma, Auto RBC Set

Lot or serial number

All lots.

Model or catalog number
  • 82616
  • 82660
  • 82666
  • 82668
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

M. Trima Accel LRS Platelet + Auto Pas, Plasma, Auto RBC Set

Lot or serial number

All lots.

Model or catalog number

82470

Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

N. Trima Accel LRS Platelet + Sampler, Plasma, RBC Set

Lot or serial number

All lots.

Model or catalog number
  • 82440
  • 82446
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

O. Trima Accel, Multiplasma Set

Lot or serial number

All lots.

Model or catalog number

82700

Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

P. Trima Accel LRS Platelet + Sampler, Multiplasma, RBC Set

Lot or serial number

All lots.

Model or catalog number
  • 82408
  • 82416
Companies
Manufacturer
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES

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