ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
FDA Recall Z-0561-2015 · Posted 2014-12-12
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Recalling FirmPfm Medical Inc
Recall StatusTerminated
Product CodeDWM
Date Initiated2014-10-20
Date Terminated2015-04-23
Product Quantity120 units
Reason for Recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Firm Action
PFm Medical sent an Urgent Device Recall Notification letter dated November 3, 2014 to all their customers who purchased the catheters and other medical devices. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the recall acknowledgement/reply form and fax it to (760) 758-1167 or email it to [email protected]. Customers with any questions are instructed to contact Jessica Greene at (760) 758-8749.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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