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Recall Observatory FDA recall evidence

Device product

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.

Z-0568-2015

October 20, 2014

Class II

Product summary

Firm
Pfm Medical Inc
Event
Event 69666
Status
Terminated
Classification
Class II
Quantity
370 units
Official record key
device-enforcement:Z-0568-2015

Official wording

Reason: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Code information: Lot No. 1210-028

Distribution pattern: Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.