PSC Industries Inc: Medical Device Recall in 2012 - (Recall #: Z-1997-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 1, 2012

Date Posted: July 18, 2012

Recall Number: Z-1997-2012

Event ID: 61958

Reason for Recall:

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.

Status: Terminated

Product Quantity: 10 units

Code Information:

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

Distribution Pattern:

Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.

Voluntary or Mandated:

Voluntary: Firm initiated