Z-2038-2014 Class II Terminated

Recalled by Pall Corporation — Port Washington, NY

Recall Details

Product Type
Devices
Report Date
July 16, 2014
Initiation Date
June 4, 2014
Termination Date
April 1, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,650 units domestically

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.

Distribution Pattern

Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.

Code Information

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