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Recall Observatory FDA recall evidence

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

June 04, 2014

Class II

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

    reason.no_named_rule · v1.0.0

    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.