Reported Jul 16, 2014 · Terminated

PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral…

Pall Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pall Corporation · 25 Harbor Park Dr · Port Washington, NY · 11050-4605

Is this the product you have?

  • 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.
Lot codes and dates
  • REF BB50T
    • Lots 326902
    • 402802
    • 405002
  • REF BB50T-BULK
    • Lots 228702
    • 229902
    • 328202
Amount recalled
24,650 units domestically

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 1, 2015 · Data as of Sep 19, 4:48 PM UTC

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