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.
FDA Recall Z-2038-2014 · Posted 2014-07-10
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Recalling FirmPall Corporation
Recall StatusTerminated
Product CodeCAH
Date Initiated2014-06-04
Date Terminated2015-04-01
Product Quantity24,650 units domestically
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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