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Fisher & Paykel Healthcare
FISHER & PAYKEL HEALTHCARE LIMITED · Model AA001M · UDI-DI 09420012433534
CAH
Prescription
10
510(k) clearances
1,004
Adverse events (41 deaths)
28
Recalls
140
Facilities
Description
Optiflow Filtered Nasal Interface
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-10 | Medline Industries, LP | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inad |
| 2025-06-16 | Draeger, Inc. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| 2025-06-16 | Draeger, Inc. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| 2025-06-16 | Draeger, Inc. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| 2025-06-16 | Draeger, Inc. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| 2025-01-09 | Kung Shin Plastics Co. Ltd. | The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable |
| 2025-01-09 | Kung Shin Plastics Co. Ltd. | The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-07-18 | Smiths Medical ASD Inc. | Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product |
| 2023-01-05 | S & MOHR AMERICA, S.A. DE C.V. | Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027" |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.