Z-2038-2014 Class II Terminated
FDA device recall Z-2038-2014 was initiated by Pall Corporation on June 4, 2014 and is designated Class II. 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. The recall status is terminated (terminated April 1, 2015). Affected quantity: 24,650 units domestically.
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