3B Medical, Inc. — Class II: React Health PHOENIX 5L Oxygen Concentrator
3B Medical, Inc. initiated a Class II recall for the React Health PHOENIX 5L Oxygen Concentrator after devices that failed to meet internal quality specifications were inadvertently distributed into the market.
This recall affects 3B Medical, Inc., distributors of the PHOENIX 5L Oxygen Concentrator, and home healthcare providers utilizing these specific devices.
The distribution of devices failing internal specifications indicates a potential breakdown in final release controls or warehouse reconciliation procedures. This suggests that the firm's Quality Management System (QMS) may need to strengthen its 'quarantine and hold' protocols to ensure non-conforming products are physically or electronically blocked from shipment. Storage and distribution processes appear to be the primary area of regulatory concern in this instance.
Quality units should perform a retrospective review of release records for current inventory to ensure all internal specifications were met prior to distribution. Regulatory teams must ensure that non-conforming material reports (NCMR) are effectively linked to distribution holds to prevent inadvertent shipments.
Class II. Reason: Devices which did not meet internal quality specifications were inadvertently distributed.. Product: React Health PHOENIX 5L Oxygen Concentrator. Firm: 3B Medical, Inc. (Dublin OH United States). Status: Ongoing.
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