Recall Z-2038-2014— Pall Corporation

Name: FDA recall Z-2038-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-04

Class II · Terminated

Class II FDA medical device recall by Pall Corporation, initiated 2014-06-04, terminated 2015-04-01. It names one FDA 510(k) clearance: K791307. 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.. 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..

Recalling firm: Pall Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Terminated: 2015-04-01
Firm location: Port Washington, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K791307 — UNIPOR BREATHING CIRCUIT FILTERPall Biomedical Products Co.·cleared 1979-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.