• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

  • Print
  • Share
  • E-mail

Product Detail

Product Description 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.
Recall Number Z-1999-2012
Classification Class II
Code Info Model/part Number: 20-0431I, Lot Number: 023340, Expiration Date: 02/28/2017.
Product Distributed Qty 125 units
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.

Event Detail

Event Id 61958
Product Type Devices
Status Ongoing
Recalling Firm PSC Industries Inc
City Louisville
State KY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-01
Initial Firm Notification of Consignee or Public Letter
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.