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U.S. Department of Health and Human Services

Class 2 Device Recall Monopolar Reusable Bayonet Forceps

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  Class 2 Device Recall Monopolar Reusable Bayonet Forceps see related information
Date Initiated by Firm June 01, 2012
Date Posted July 12, 2012
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-1995-2012
Recall Event ID 61958
510(K)Number K982705  
Product Classification Electrosurgical, cutting, coagulation, accessories - Product Code GEI
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.
Code Information Model/part Number: 41604, Lot Number: 019737, and 021578.
Recalling Firm/
Manufacturer		 PSC Industries Inc
3230 Commerce Center Pl
Louisville KY 40211-1900
For Additional Information Contact Victoria Rogers (NMI)
615-964-5515
Manufacturer Reason
for Recall		 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).
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, Olsen Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 5, 2012 to their customers via Certified mail along with representative labeling to illustrate the specific labeling issue associated with the various types and/or sizes of Bayonet Forceps surgical instruments that the customers received. The letter described the product, problem and actions to be taken. The letter instructed the customers to immediately examine their inventory for the presence of the suspect product and quarantine the product, if found; to discontinue use immediately and promptly call (800) 251-3000 for a 'Return Material Authorization (RMA) number; to complete and return the enclosed 'Recall Response Form' and fax the completed form to the fax number on the form or to send the completed form back to the recalling firm via parcel post, and for customers who may have further distributed the recalled product are asked to contact their (sub-account) customers and notify them of the recall. If you have any questions call (615) 964-5515 M-F 8:00 am - 5:00 pm CST.
Quantity in Commerce 5 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = ITI MEDICAL TECHNOLOGIES, INC.
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