Recall Z-0037-2015— Richard Wolf Medical Instruments Corp.
Class II · Terminated
Class II FDA medical device recall by Richard Wolf Medical Instruments Corp., initiated 2014-07-09, terminated 2017-04-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-09
- Terminated
- 2017-04-24
- Firm location
- Vernon Hills, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.