Stryker Mistral-Air Premium Blankets Recalled for Electrical Conductivity Risk
Stryker is recalling Mistral-Air Premium Blankets because they may conduct electricity during high-energy defibrillation if applied upside down.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of electrical injury during high-energy medical procedures, which aligns with the 'Severe' criteria for significant injury potential.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 11,160 units of MA3320-PM Premium Adult SYK Mistral-Air Premium Blankets (Model # MA3302-PM, Catalog # MA3302-PM). The affected units are identified by lot numbers 1640002 and 1645003 and were distributed in the U.S.
The recall was initiated because the blankets may be capable of conducting electricity during defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) if the blanket is applied with the reflective side toward the patient (upside down). This specific orientation creates a risk of electrical conduction during high-energy procedures.
Healthcare facilities and consumers should check their inventory for these specific model and lot numbers. If the product is found, it should be removed from use and returned to Stryker or the distributor according to the recall instructions.
The recalled product
- Product
- MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Patient Warming
- Affected units
- 11,160
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 (2)
- LOT #(s): 1640002
- 1645003
Distribution
Distribution scope not specified by the agency.
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