Health product recall

Adult IV Set with Rate Flow Regulator, Rate Flow Regulator Extension Set, and Rate Flow Regulator IV Set (2018-10-01)

Starting date:
October 1, 2018
Posting date:
October 26, 2018
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-68078

Affected products

  1. Adult IV Set with Rate Flow Regulator
  2. Rate Flow Regulator Extension Set
  3. Rate Flow Regulator IV Set

Reason

Manufacturer has reviewed recently reported deficiencies related to validation and process control of the manufacturing facility of the rate flow regulator administration sets and, out of an abundance of caution, B. Braun Medical Inc. has elected to remove this product from the market.

Affected products

  1. Adult IV Set with Rate Flow Regulator

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

V59222

Companies
Manufacturer
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES

B. Rate Flow Regulator Extension Set

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

US5300
V5200

Companies
Manufacturer
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES

C. Rate Flow Regulator IV Set

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

375152

Companies
Manufacturer
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES