FDA Device recall Z-0037-2015

The Hulka Clip is a sterile packaged medical device that carries a two year expiration date

• FDA Device
• Class II
• terminated
• Published 2014-10-15

On 2014-10-15 the FDA classified a Class II recall of The Hulka Clip is a sterile packaged medical device that carries a two year expiration date by Richard Wolf Medical Instruments, citing 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 biocom….

Read the official FDA Device notice

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0037-2015%22

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