Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700

Recall Insight

This FDA Devices action (record #Z-1278-2022) was formally reported on June 29, 2022, with the manufacturer initiating the action on May 2, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Getinge Usa Sales Inc is listed as the recalling firm, operating out of Wayne, NJ. Federal records indicate 17 units US units are affected.

The documented reason for this recall is: 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 acti… Distribution data in the federal record shows the product reached: US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.