LSR Paediatric Cpl. w/Masks in Disp.Case (IE)
Laerdal Medical AS · Model 86005533 · UDI-DI 07045430012349
Description
The Laerdal Silicone Resuscitator is a self-inflating manual resuscitator that is intended for patients requiring total or intermittent ventilatory support. The Laerdal Silicone Resuscitator provides positive pressure ventilation and allows spontaneous breathing either with a 22 mm ID (inner diameter) face - mask port, through an artificial airway or with a facemask that has a 15 mm OD (outer diameter) connection. The Preterm model is intended for patients below 2,5 kg (5,5 lb), the Paediatric model is intended for patients from 2,5 (5,5 lb) to 25 kg (55 lb), and the Adult model is intended for pati - ents over 25 kg (55 lb).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-08 | Datex-Ohmeda Inc | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration se |
| 2025-07-09 | Ambu Inc. | Potential for the manometer port being blocked rendering the manometer non-functional. |
| 2025-05-01 | SunMed Holdings, LLC | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there wou |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
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