Device recall: The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips…
Class II FDA enforcement event 68777. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Richard Wolf Medical Instruments Corp. started this device recall on 9 Jul 2014. The firm address in the FDA record is in Vernon Hills, IL. FDA put the recall in Class II. FDA event 68777 has 1 product record. The first FDA enforcement report date is 15 Oct 2014. The record gives the status Terminated, with the termination date 24 Apr 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.
Recalling firm
Richard Wolf Medical Instruments Corp., Vernon Hills, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0037-2015 | 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. | 73 cartons (1,460 clips) | Class II | Terminated | 15 Oct 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 May 2019 | E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted int | Device | Class II | 1 |
| 19 May 2016 | Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic acces | Device | Class II | 1 |
| 29 Feb 2016 | The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative pr | Device | Class II | 1 |
| 25 Nov 2015 | Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powere | Device | Class II | 3 |
| 10 Dec 2014 | The I-Cart is used to store, transport, and power video equipment used in medical procedures. | Device | Class II | 1 |
| 18 Sep 2013 | Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telesco | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0037-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 68777. https://recallregister.com/fda/ii/68777/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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.
- What quantity of product is in FDA event 68777?
- The FDA record gives this quantity:
73 cartons (1,460 clips)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.