FDA Medical Device Recalls (openFDA)
Pall Corporation: 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.
- Recall number
- Z-2038-2014
- Recalling firm
- Pall Corporation
- 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.
- Status
- Terminated
- Initiated
- 2014-06-04
- Posted
- 2014-07-10
- Terminated
- 2015-04-01
- 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.
- Root cause
- Other
- Action
- Urgent Product Recall Letters (dated 6/03/2014) and Response Forms were sent to customers via fax and e-mail starting on 6/04/14. The letters instruct the direct accounts to examine their inventory and place the affect lots on hold in quarantine. For questions, or if a patient injury associated with this device has been reported to you, please call Karen Peterson directly at 516.801.9267 (office) or 516.644.6171 (cell). The letter for the bulk product also instructs customers to notify their customers of the recall and advise them not use the affected lots if the product had been distributed.
- Quantity
- 24,650 units domestically
- Distribution
- Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.
- Lot, serial or model codes
- REF BB50T: Lots 326902, 402802, 405002; REF BB50T-BULK: Lots 228702, 229902, 328202
- 510(k) numbers
- ["K791307"]
- PMA numbers
- not on file
- Product code
- CAH
- Firm FEI
- 2432733
- Firm city
- Port Washington
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28