FDA-Device2014-07-16Class II
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.
Pall Corporation
Hazard
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.
Sold states
Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.
Affected count
24,650 units domestically
Manufactured in
25 Harbor Park Dr, Port Washington, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2038-2014Don't want to check this manually?
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