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
- Adult IV Set with Rate Flow Regulator
- Rate Flow Regulator Extension Set
- 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
-
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