The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0037-2015·Announced 2014-10-15

Richard Wolf Recalls Hulka Clip Tubal Occluding Device Lot 51000232

Richard Wolf Medical Instruments is recalling Hulka Clip Tubal Occluding Devices (Lot 51000232) due to a biocompatibility test discrepancy found in a subsequent lot.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a biocompatibility test discrepancy in a medical device. No illnesses or injuries are reported in the source text, and the hazard is theoretical based on the failed test of a subsequent lot, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Richard Wolf Medical Instrument Corporation is recalling the Hulka Clip Tubal Occluding Device, specifically Lot 51000232. The recalled devices are sterile packaged medical devices that carry a two-year expiration date. They are packaged two clips per procedural tray, sealed in a Tyvek/Mylar pouch, and shipped in cardboard cartons containing ten pouches each. The recall involves 73 cartons, totaling 1,460 clips.

The recall is being conducted as part of an investigation into a biocompatibility test discrepancy. The recalled lot (51000232) passed final release testing; however, a subsequent lot failed biocompatibility testing on a component that was also used to manufacture the recalled lot. The agency has classified this recall as Class II.

The affected devices were distributed worldwide, including nationwide distribution in the United States (specifically in 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 in Germany. Consumers and healthcare providers should stop using the affected lot and contact the manufacturer for further instructions.

The recalled product

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…
Manufacturer
Richard Wolf Medical Instruments Corp.
Category
Medical Device — Tubal Occlusion
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product Code: 4986.09
  • Lot: 51000232

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

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