Hulka Clip for Tubal Occlusion

• • Terminated Z-0037-2015 FDA Class II ·initiated 9 Jul 2014

  Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.

• • Terminated Z-0272-2010 FDA Unclassified (pre-2012) ·initiated 16 Oct 2009 ·on shared PMA P870080

  The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Generic Name

Laparoscopic contraceptive tubal occlusion device

PMA Number

P870080 ↗

FDA Product Code

KNH

Device Class

Class III

Regulation

21 CFR Part 884.5380

Advisory Committee

Obstetrics/Gynecology

FDA Decision

APWD Approval withdrawn

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