Home / Recalls / Richard Wolf Medical Instruments Corp. / Z-0037-2015

Z-0037-2015 Class II Terminated

Recalled by Richard Wolf Medical Instruments Corp. — Vernon Hills, IL

Recall Details

Product Type
Devices
Report Date
October 15, 2014
Initiation Date
July 9, 2014
Termination Date
April 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
73 cartons (1,460 clips)

Product Description

The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.

Reason for Recall

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.

Distribution Pattern

Worldwide distribution: US (Nationwide) including states of: (AK, AL, CO, CT, FL, GA, IA, IN, KY, LA, MI, MO, MS, NC, NY, OH, OR, PA, SC, TN, TX, VA, WA, WV; and country of: Germany.

Code Information

Product Code: 4986.09; Lot: 51000232

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  • Z-0791-2016 Class II — Reuseable rotary blade/abrader, product number 899751514. The oval burr frontal (November 25, 2015)
  • Z-1240-2015 Class II — The I-Cart is used to store, transport, and power video equipment used in medica (December 10, 2014)
  • Z-0145-2014 Class II — Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vapo (September 18, 2013)