Cocoon Convective Warming System Recalled for Thermal Damage Risk
Care Essentials is recalling 689 Cocoon Convective Warming Systems due to a risk of thermal damage near the power cord connector and Power Entry Module.
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 involves a risk of thermal damage (burns) from a medical device, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Care Essentials Pty., Ltd. is recalling 689 units of the Cocoon Convective Warming System, Product Code CWS4000 (110V). The recall is due to a potential for thermal damage near the power cord connector and Power Entry Module (PEM) caused by improper connection of the power cord connector and PEM pins.
The affected units were distributed nationwide in the United States to the states of AZ, CA, FL, GA, KS, LA, MA, MD, MI, MN, NC, NM, NY, OH, PA, QC, SC, TX, VA, and WV, as well as to Canada. The specific serial numbers affected are listed in the official recall documentation.
Consumers should stop using the affected Cocoon Convective Warming Systems immediately and contact Care Essentials Pty., Ltd. for instructions on how to resolve the issue.
The recalled product
- Product
- Cocoon Convective Warming System, Product Code: CWS4000 (110V).
- Manufacturer
- Care Essentials Pty., Ltd.
- Category
- Medical Device — Patient Warming
- Affected units
- 689
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 (20)
- Product Code: CWS4000 (110V) Serial Numbers: CWS4-10001-14
- CWS4-10002-14
- CWS4-10003-14
- CWS4-10004-14
- CWS4-10005-14
- CWS4-10006-14
- CWS4-10007-14
- CWS4-10008-14
- CWS4-10009-14
- CWS4-10010-14
- CWS4-10011-14
- CWS4-10012-14
- CWS4-10013-14
- CWS4-10014-14
- CWS4-10015-14
- CWS4-10016-14
- CWS4-10017-14
- CWS4-10018-14
- CWS4-10020-14
- CWS4-10021-14
Distribution
Part of a larger recall action
This product is one of 2 recalled by Care Essentials Pty., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Care Essentials Pty., Ltd.
See all →- HighCocoon Convective Warming System Recalled for Thermal Damage Risk
FDA (Devices) · 2020-02-12
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