Recall record at a glance
| Official record | Z-0092-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Getinge Group Logistics America, LLC |
| Report date | Oct 21, 2020 |
| Recall initiation date | Sep 17, 2020 |
| Quantity | 431 units |
| Location | Wayne, NJ, United States |
Official product description
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
Why the product was recalled
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
Distribution information
Domestic distribution to AZ CA GA IL MN MO NC NJ NY RI SC TX VA WI WV Foreign distributed to Bosnia and Herzegovina, Czech Republic, France, Germany, India, Indonesia, Iraq, Italy, Kenya, Republic of Korea, Lebanon, Libyan Arab Jamahiriya, Norway, Palestine, Peru, Qatar, Saudi Arabia,Slovakia, Sri Lanka, Sweden Thailand, Turkmenistan, Ukraine and United Arab Emirates.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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