Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of pat
Summary
The FDA issued a Class I for Flow-c Anesthesia System : intended for use in administering anesthesia while c by Getinge Usa Sales Inc. Reason: Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst ca.
Details
Source
Device Recall
External ID
Z-1278-2022
Action Date
2022-06-29
Status
Terminated
Category
device
Product Description
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Lot/Code Info: UDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078. (Note: UDI was corrected July 7, 2022)
Quantity Affected: 17 units US
Reason for Recall
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Distribution
US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-02
Company
Wayne, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 107 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Usa Sales Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Usa Sales Inc have FDA actions?
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1278-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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