The Recall Desk
HighFDA (Devices)·Z-2038-2014·Announced 2014-07-16

Pall Medical Breathing Circuit Filter Recall for Possible Air Leak

Pall Corporation is recalling specific lots of Medical Breathing Circuit Filters due to a possible leak at the filter end cap junction.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (air leak) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Pall Corporation is recalling specific lots of PALL Medical Breathing Circuit Filters (REF BB50T and BB50T-BULK). These are single-use, bi-directional bacterial/viral removal filters intended for prescription use only. The recall involves 24,650 units distributed domestically in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.

The recall is being issued because of a possible leak from the filter that allows a small amount of air to be released from the junction between the filter end cap (flat side of the filter) and the filter housing connection. The affected lots are 326902, 402802, and 405002 for REF BB50T, and 228702, 229902, and 328202 for REF BB50T-BULK.

Healthcare facilities and consumers who have these specific lots should stop using the filters and contact Pall Corporation for instructions on return or replacement. The filters are individually packaged in clear plastic pouches with black writing, or in bulk packaging of 100 filters per bag.

The recalled product

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
Manufacturer
Pall Corporation
Category
Medical Device — Respiratory Filter
Hazard
Affected units
24,650

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • REF BB50T: Lots 326902
  • 402802
  • 405002
  • REF BB50T-BULK: Lots 228702
  • 229902
  • 328202

Distribution

Distributed in 15 states:

Related recalls

Same hazard · air leak

See all →