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Recall Observatory FDA recall evidence

Device product

ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

Z-0562-2015

October 20, 2014

Class II

Product summary

Firm
Pfm Medical Inc
Event
Event 69666
Status
Terminated
Classification
Class II
Quantity
1470 units
Official record key
device-enforcement:Z-0562-2015

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. 1307-065, 1301-009

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.