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Health product recall

Pedi-Pack Quad Transfer Pak and Pedi-Syringe Filters (2013-09-06)

Starting date:
September 11, 2013
Posting date:
October 16, 2013
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-36213

Recalled Products

A. Pedi-Pak Quad 75 mL Transfer Pak w/o Filter
B. Pedi-Pak Pedi-Syringe Filter 30 mL
C. Pedi-Pak Pedi-Syringe Filter 35 mL
D. Pedi-Pak Pedi-Syringe Filter 60 mL (BD)
E. Pedi-Pak Pedi-Syringe Filter 60 mL (MJ)

Reason

Sale of unlicensed medical devices.

Affected products

A. Pedi-Pak Quad 75 mL Transfer Pak w/o Filter

Lot or serial number
  • 9680-34326
Model or catalog number
  • 402-504
Companies
Manufacturer
Genesis BPS LLC
65 Commerce Way
Hackensack
07601
New Jersey
UNITED STATES

B. Pedi-Pak Pedi-Syringe Filter 30 mL

Lot or serial number
  • 3640-23476
  • 3640-23506
  • 3640-24153
  • 3640-24206
  • 3640-24398
  • 3640-24485
  • 3640-24517
Model or catalog number
  • 405-530BD
Companies
Manufacturer
Genesis BPS LLC
65 Commerce Way
Hackensack
07601
New Jersey
UNITED STATES

C. Pedi-Pak Pedi-Syringe Filter 35 mL

Lot or serial number
  • 3620-23970
  • 3620-24518
Model or catalog number
  • 405-535MJ
Companies
Manufacturer
Genesis BPS LLC
65 Commerce Way
Hackensack
07601
New Jersey
UNITED STATES

D. Pedi-Pak Pedi-Syringe Filter 60 mL (BD)

Lot or serial number
  • 3650-23508
  • 3650-24116
  • 3650-24332
  • 3650-24399
  • 3650-24487
  • 3650-24519
Model or catalog number
  • 405-560BD
Companies
Manufacturer
Genesis BPS LLC
65 Commerce Way
Hackensack
07601
New Jersey
UNITED STATES

E. Pedi-Pak Pedi-Syringe Filter 60 mL (MJ)

Lot or serial number
  • 3630-23509
  • 3630-23972
  • 3630-24181
  • 3630-24333
  • 3630-24397
  • 3630-24488
Model or catalog number
  • 405-560MJ
Companies
Manufacturer
Genesis BPS LLC
65 Commerce Way
Hackensack
07601
New Jersey
UNITED STATES

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