[724254]
Cci makes the airzone peak flow meter with the ats scale for united states sale. Cci manufactured a batch of airzone peak flow meters with the liter flow scale misapplied upside down so that the air flow from the lungs would be reversed. The scale in correct position shows the force of the air exhaled from the lungs. Larger flows show good function and patient is controling asthma. With the scale upside down, the pt would get a low number which would not correlate to feeling good. The instructions from the physician would be for the pt to contact the dr if the rate falls. This is also stated in product instructions. Distributor rec'd notice of this defect on aug 6, from our distributor. Distributor notified clement clarke of the issue immediately. We then recalled all product form the distributor, searched the lot number and manually inspected remaining inventory at distributor. All mislabeled products have been quarantined by distributor and are being returned to clement clarke. The total units mislabeled in the usa. Distributor has completed a review of the issue and will increase number of units inspected. Clement clarke has initiated a capa to review there inventory of the product, lot number in question and all other lots. A total units were found, quarantined and product repackaged for purchase. Cci then initiated a capa, retrained assemblers and operators, a new master sample, first article sample is made and inspected to meet specifications on each shift. This sample is used as in-process production models to compare to during production of the build set. All products have been consumed and due to the time in the market, there are no indications that any intervention of any kind was required. There are no remaining mislabeled units in the market to the best of our knowledge.
Patient Sequence No: 1, Text Type: D, B5