PSC Industries Inc: 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.; 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 the outer carton label of this sterile, single use

Agency Publication Date: July 12, 2012

Affected Products

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 in coagulating tissue during surgical procedures.

Model/part Number: 90-7004, Lot Numbers: 017897

Lot Numbers:

Numbers

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 tissue during surgical procedures.

Model/part Number: 41604, Lot Number: 019737, and 021578.

Lot Numbers:

Number

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 - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.

Model/part Number: 20-1360I, Lot Number: 023399, Expiration Date: 02/28/2017.

Lot Numbers:

Number

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 Forceps and Cords are intended for use in coagulating tissue during surgical procedures

Model/part Number: 20-11420, Lot Number: 023340, Expiration Date: 2/28/2017.

Lot Numbers:

Number

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 - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.

Model/part Number: 20-1360K, Lot Number: 023420,, Expiration Date: 2/28/2017.

Lot Numbers:

Number

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. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.

Model/part Number: 20-0431I, Lot Number: 023340, Expiration Date: 02/28/2017.

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61958

Status: Resolved

Manufacturer: PSC Industries Inc

Manufactured In: United States

Units Affected: 6 products (7 units; 5 units; 80 units; 10 units; 40 Units; 125 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Model/part Number: 90-7004, Lot Numbers: 017897

Lot Numbers:

Numbers

Model/part Number: 41604, Lot Number: 019737, and 021578.

Lot Numbers:

Number

Model/part Number: 20-1360I, Lot Number: 023399, Expiration Date: 02/28/2017.

Lot Numbers:

Number

Model/part Number: 20-11420, Lot Number: 023340, Expiration Date: 2/28/2017.

Lot Numbers:

Number

Model/part Number: 20-1360K, Lot Number: 023420,, Expiration Date: 2/28/2017.

Lot Numbers:

Number

Model/part Number: 20-0431I, Lot Number: 023340, Expiration Date: 02/28/2017.

Lot Numbers:

Number