Z-0037-2015Class II

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

Name: Z-0037-2015 The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged...
Creator: Richard Wolf Medical Instruments Corp.
Published: 2014-07-09
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2014-07-09 / Terminated / root cause: manufacturing process

FDA source

Richard Wolf Medical Instruments Corp. began a recall of 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... on 2014-07-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0037-2015
Classification: Class II
Status: Terminated
Initiated: 2014-07-09
Posted: 2014-11-06
Terminated: 2017-04-24
Recalling firm: Richard Wolf Medical Instruments Corp.
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.
Product code: KNH Laparoscopic Contraceptive Tubal Occlusion Device
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: "Urgent: Medical Device Recall" letters dated July 9, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) inspect their inventories for the recalled products; 2) contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380 to notify Richard Wolf Medical Instruments if you have any devices in inventory; 3) review your records and report the number, if any, of Hulka Clips from lot 51000232 that were implanted in your patients on the Recall Response Form; 4) complete and return the Recall Response Form attached to the letter; and, 5) a RMA number will be provided to customers returning the recalled products and those customers will receive a credit. All returned product should be sent to the attention of Ms. Lisa Williams, Regulatory Specialist. Customers with questions can contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380.
Quantity in commerce: 73 cartons (1,460 clips)
Distribution: 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.
Product codes and lots: Product Code: 4986.09; Lot: 51000232

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0037-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0037-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-07

Product code KNH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)