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Note 14 - Subsequent Events
3 Months Ended
Mar. 31, 2022
Notes to Financial Statements  
Subsequent Events [Text Block]

NOTE 14 SUBSEQUENT EVENTS

 

Subsequent to March 31, 2022, due to information identified during the Corrective Action Preventative Action (CAPA) investigation of the Epidural Disposable Kit, Part # 6100-01, lot HC 51 the scope of the voluntary market withdrawal needed to be expanded to include Part # 6100-03, lot HC 50. A new non-conformance was initiated and Lot HC 50 was added to the scope of the CAPA initiated above. The investigation via the CAPA identified that there is an issue with the id adaptors used in both lots HC 51 and HC 50. However, the health hazard evaluation shows that there is no risk to the patient or the user, thus management has determined there are no potential impacts to patients or users. Lots HC 51 and HC 50 are worth approximately $22,000 and $10,000 respectively. Management has not yet determined what the final disposition of the affected inventory will be after the market withdrawal is completed.

 

Subsequent to March 31, 2022, the Company was notified that some of the Wand STA handpieces, reference # STA—5050-2725, lot B210113 were packaged incorrectly. The Company initiated a Corrective Action Preventative Action (CAPA) investigation to determine the root cause and implement corrective actions. The Health Hazard Evaluation (HHE) was completed and showed that there is no risk to the patient or the user due to this discrepancy, thus management has determined there are no potential impacts to patients or users. However, to provide the highest quality products to the market, Milestone Scientific decided to initiate a voluntary market withdrawal on May 13, 2022. Lot B210113 is worth approximately $25,000. Management has not yet determined what the final disposition of the affected inventory will be after the market withdrawal is completed.