The Recall Desk

FDA (Devices) recall action 61958

PSC Industries Inc recalled 6 products on 2012-07-18

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2012-07-18
Critical
0
Units
267

Why these products were recalled

Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label.

Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is: (0.5mm) when the tip size actually measures (1.0mm).

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • LowFDA (Devices)··2012-07-18

    PSC Industries Recalls Surgical Forceps Due to Labeling Errors

    PSC Industries is recalling 40 units of Model #20-1360K surgical forceps because of typos in the inner packaging labels. The errors did not affect the part or lot numbers.

    Product
    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…
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2012-07-18

    PSC Industries Recalls Surgical Forceps Due to Labeling Errors

    PSC Industries is recalling Bayonet Forceps due to typos in the inner packaging labels. The errors did not affect the part or lot numbers.

    Product
    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…
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2012-07-18

    PSC Industries Recalls Misbranded Electrosurgical Bayonet Forceps

    PSC Industries is recalling 5 units of Model #41604 Bayonet Forceps because the label incorrectly states the tip size is 0.5mm when it is actually 1.0mm.

    Product
    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…
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2012-07-18

    PSC Industries Recalls Irrigating Bayonet Forceps Due to Labeling Errors

    PSC Industries is recalling 125 units of Irrigating Bayonet Forceps because of typographical errors on the inner packaging labels.

    Product
    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.…
    Category
    Distribution
    10 states
  • LowFDA (Devices)··2012-07-18

    PSC Industries Recalls Bipolar Bayonet Forceps Due to Packaging Labeling Error

    PSC Industries is recalling 7 units of Bipolar Bayonet Forceps because the manufacturer symbol was incorrectly replaced by the expiry symbol on the packaging.

    Product
    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…
    Category
    Distribution
    10 states
  • LowFDA (Devices)··2012-07-18

    PSC Industries Recalls Bayonet Forceps Due to Incorrect Expiration Date

    PSC Industries is recalling 80 units of Bayonet Forceps because the outer carton lists an incorrect sterile expiration date, though the individual pouch labels are correct.

    Product
    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…
    Category
    Distribution
    10 states