LEVEL 1® Fast Flow and Irrigation Fluid Warming Systems (2021-08-11)
- Starting date:
- August 11, 2021
- Posting date:
- August 27, 2021
- 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-76319
Last updated: 2021-08-27
Affected Products
A. Fluid warming systems and compressors
B. LEVEL 1 NORMOFLO IRRIGATION WARMING SETS (DISPOSABLE)
C. NORMOFLO IRRIGATION FLUID WARMER
D. FLUID WARMING SYSTEM W/TWO PRESSURE INFUSERS/BUILD IN AIR DETECTOR CLAMP
E. LEVEL 1 NORMOTHERMIC I.V. FLUID ADMINISTRATION SET
Reason
The FDA has recently been in communication with multiple medical device manufacturers concerning the potential for aluminum leaching from fluid warming systems. Many of these devices were developed and approved by the agency prior to the availability of modern analytical technology used to detect aluminum at the threshold limits present in the regulations. The FDA has had several communications with Smiths Medical regarding the potential for aluminum leaching from our level 1 fast flow fluid warming systems and normoflo products. While published studies conducted by Smiths Medical have been presented to them indicating that under normal use these devices meet acceptable limits in regard to aluminum leaching, they disagreed with that assessment and requested that a draft recall notification package be submitted. For consistency, we are notifying all geographies where these products are marketed of this advisory notice developed in response to the FDA request.
Affected products
A. Fluid warming systems and compressors
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H-1000
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis
55442
Minnesota
UNITED STATES
B. LEVEL 1 NORMOFLO IRRIGATION WARMING SETS (DISPOSABLE)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- IR-40
- IR-500
- IR-600
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis
55442
Minnesota
UNITED STATES
C. NORMOFLO IRRIGATION FLUID WARMER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- H-1129
- H1100
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis
55442
Minnesota
UNITED STATES
D. FLUID WARMING SYSTEM W/TWO PRESSURE INFUSERS/BUILD IN AIR DETECTOR CLAMP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H-1200-EN-115V
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis
55442
Minnesota
UNITED STATES
E. LEVEL 1 NORMOTHERMIC I.V. FLUID ADMINISTRATION SET
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- D-100
- D-60HL
- DI-100
- DI-50
- DI-60HL
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis
55442
Minnesota
UNITED STATES