This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The shelf life of this product is 10 years from the date of manufacturing as always specified on the pick slip going out with the product from distribution center.Therefore, the expiration date labeled on the box was misleading and not actually referring to the life of the item inside the box.It was intended to informing the customer of next date the enclosed battery pack must be charged to stay alive if in storage more than a year which is always one (1) year from the last charge date on the battery storage label next to it.In conclusion, the product shipped to the customer has not expired and is not expiring, nor pose any safety or health hazard to patients.The issue is purely a process failure due to incorrect labeling /symbol chosen to reference battery recharging date which needed to be addressed added to a lapse in inventory control.As a result, non conformance has been raised for further investigation and process review.
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