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U.S. Department of Health and Human Services

Class 2 Device Recall PALL Medical Breathing Circuit Filter

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  Class 2 Device Recall PALL Medical Breathing Circuit Filter see related information
Date Initiated by Firm June 04, 2014
Date Posted July 10, 2014
Recall Status1 Terminated 3 on April 01, 2015
Recall Number Z-2038-2014
Recall Event ID 68424
510(K)Number K791307  
Product Classification Filter, bacterial, breathing-circuit - Product Code CAH
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.
Code Information REF BB50T: Lots 326902, 402802, 405002;  REF BB50T-BULK: Lots 228702, 229902, 328202
Recalling Firm/
Manufacturer		 Pall Corporation
25 Harbor Park Dr
Port Washington NY 11050-4605
For Additional Information Contact Karen Peterson-Doyle
516-484-5400
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAH and Original Applicant = PALL BIOMEDICAL PRODUCTS CO.
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