[pending] Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Numb
Pending LLM rewrite. Source: FDA_DEVICE Z-1341-2026.
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
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
The recalled product
- Product
- Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
- Manufacturer
- Laerdal Medical Corporation
- 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 (12)
- 1) LCSU 4
- 800 ml
- RTCA
- Catalog Number: 880052
- UDI-DI: 07045432088519
- 2) LCSU 4
- 300 ml
- Catalog Number: 880062
- UDI-DI: 07045432088533
- 3) LCSU 4
- Catalog Number: 881152
- UDI-DI: 07045432067132
Distribution
Distributed nationwide across the United States.
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