Z-0037-2015 Class II Terminated
FDA device recall Z-0037-2015 was initiated by Richard Wolf Medical Instruments Corp. on Jul 9, 2014 and is designated Class II. 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… The recall status is terminated (terminated Apr 24, 2017). Affected quantity: 73 cartons (1,460 clips).
Recall Details
- Product Type
- Devices
- Report Date
- Oct 15, 2014
- Initiation Date
- Jul 9, 2014
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0037-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026