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Terminated

ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.

FDA Recall Z-0568-2015 · Posted 2014-12-12

Recalling FirmPfm Medical Inc
Recall StatusTerminated
Product CodeFJS
Date Initiated2014-10-20
Date Terminated2015-04-23
Product Quantity370 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.

K113354VETA PERITONEAL DIALYSIS CATHETERPfm Medical, Inc. · 2012-03-13K093796ASEPT PERITONEAL DRAINAGE SYSTEMPfm Medical, Inc. · 2010-02-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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