Smiths Medical Recalls Snuggle Warm Sterile Cardiac Warming Blankets
Smiths Medical ASD, Inc. is recalling 2,120 Snuggle Warm Sterile Cardiac Connective Warming Blankets because the hose could separate from the blanket.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 2,120 units of the SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket. These devices are used with the Equator Convective Warmer to regulate a patient's temperature and prevent hypothermia or cold discomfort during and after surgical procedures.
The recall is being issued because the hose could separate from the blanket. The affected units were distributed worldwide, including in the United States states of California, Illinois, Kentucky, Mississippi, North Carolina, Tennessee, Texas, Washington, and Wisconsin, as well as in Bahrain, Germany, Norway, and Russia.
The affected lot numbers are 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, and 2615712. Healthcare facilities should stop using these devices and contact Smiths Medical ASD, Inc. for instructions on how to return or dispose of them.
The recalled product
- Product
- SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 2,120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot: 1006733
- 2474599
- 2488138
- 2523531
- 2536250
- 2558180
- 2563033
- 2564447
- 2564448
- 2615712
Distribution
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