Device recall: Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k)…
Class II FDA enforcement event 61958. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.
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
PSC Industries Inc started this device recall on 1 Jun 2012. The firm address in the FDA record is in Louisville, KY. FDA put the recall in Class II. FDA event 61958 has 6 product records. The first FDA enforcement report date is 18 Jul 2012. The record gives the status Terminated, with the termination date 15 Sep 2015.
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: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
Recalling firm
PSC Industries Inc, Louisville, KY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1994-2012 | Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical… | 7 units | Class II | Terminated | 18 Jul 2012 |
| Z-1995-2012 | Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures. | 5 units | Class II | Terminated | 18 Jul 2012 |
| Z-1996-2012 | Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are… | 80 units | Class II | Terminated | 18 Jul 2012 |
| Z-1997-2012 | Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in… | 10 units | Class II | Terminated | 18 Jul 2012 |
| Z-1998-2012 | Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are… | 40 Units | Class II | Terminated | 18 Jul 2012 |
| Z-1999-2012 | Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended… | 125 units | Class II | Terminated | 18 Jul 2012 |
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 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 6Median of the firm: 6
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Jun 2012 | Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-1994-2012The 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 61958. https://recallregister.com/fda/ii/61958/. 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: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
- What quantity of product is in FDA event 61958?
- The event has 6 product records. The first record gives this quantity:
7 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.