U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Possible leak from the filter allowing a small of amount of air to be released from the junction between the filter end cap (flat side of the filter) and the filter housing connection.
조치
Urgent Product Recall Letters (dated 6/03/2014) and Response Forms were sent to customers via fax and e-mail starting on 6/04/14. The letters instruct the direct accounts to examine their inventory and place the affect lots on hold in quarantine. For questions, or if a patient injury associated with this device has been reported to you, please call Karen Peterson directly at 516.801.9267 (office) or 516.644.6171 (cell). The letter for the bulk product also instructs customers to notify their customers of the recall and advise them not use the affected lots if the product had been distributed.
Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.
제품 설명
PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. || The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two bags per shipper for a total of 200 filters/shipper.