[pending] Therapy Mask 3100 NC/SP
Pending LLM rewrite. Source: FDA_DEVICE Z-1784-2022.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
The recalled product
- Product
- Therapy Mask 3100 NC/SP
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Devices
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)
- All Units
- Model No.: 1144608
- 1144610
- 1145038
- 1145039
- 1145040
- 1145041
- 1145044
- 1145045
- 1145046
- 1145047
- 1145048
- 1145049
- 1145050
- 1145051
- 1145052
- 1145055
- 1145056
- 1145057
- 1145058
Distribution
Distributed nationwide across the United States.
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