Z-2038-2014Class II

PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional...

Name: Z-2038-2014 PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional...
Creator: Pall Corporation
Published: 2014-06-04
License: https://open.fda.gov/license/

Pall Corporation / initiated 2014-06-04 / Terminated

FDA source

Pall Corporation began a recall of PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are... on 2014-06-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2038-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Posted: 2014-07-10
Terminated: 2015-04-01
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.
Product code: CAH Filter, Bacterial, Breathing-Circuit
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: REF BB50T: Lots 326902, 402802, 405002; REF BB50T-BULK: Lots 228702, 229902, 328202

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2038-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2038-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-10

Product code CAH

K791307Class IIUnipor Breathing Circuit FilterPall Biomedical Products Co. / cleared 1979-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)