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PALL Medical Breathing Circuit Filter, REF BB50T and… recallZ-2038-2014 · Pall Corporation · initiated Jun 4, 2014

Class II Terminated All recalls posted in July 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Pall Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-2038-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 4, 2014
Posted by the FDA
Jul 10, 2014
Recalling firm
Pall Corporation
Quantity
24,650 units domestically
Product code
CAH
FDA submissions
K791307
Distribution
Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

3 devices cleared under K791307 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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