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U.S. Department of Health and Human Services

Class 2 Device Recall Bipolar Sterile Single Use 71/8 Electrosurgical Bayonet Forceps

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  Class 2 Device Recall Bipolar Sterile Single Use 71/8 Electrosurgical 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-1996-2012
Recall Event ID 61958
510(K)Number K884656  
Product Classification Electrosurgical, cutting, coagulation, accessories - Product Code GEI
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.
Code Information Model/part Number: 20-1360I, Lot Number: 023399, Expiration Date: 02/28/2017.
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 the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the manufacture date] ; however the device pouch label lists the sterile date as: 2017-02-(28). The pouch label lists the correct sterile expiration date.
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 80 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 = DERMACARE
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