Device product
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.
Z-2038-2014
Product summary
- Firm
- Pall Corporation
- Event
- Event 68424
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,650 units domestically
- Official record key
device-enforcement:Z-2038-2014
Official wording
Reason: 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.
Code information: REF BB50T: Lots 326902, 402802, 405002; REF BB50T-BULK: Lots 228702, 229902, 328202
Distribution pattern: Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.
Derived failure modes
-
Unknown
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.