Recall Z-2038-2014 ยท CAH Filter, Bacterial, Breathing-Circuit
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.
| Date | Jul 10, 2014 (initiated Jun 4, 2014) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791307 | UNIPOR BREATHING CIRCUIT FILTER Pall Biomedical Products Co., Aug 3, 1979 |