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U.S. Department of Health and Human Services

Class 2 Device Recall Biopsy Forceps, Hot

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  Class 2 Device Recall Biopsy Forceps, Hot see related information
Date Initiated by Firm August 08, 2008
Date Posted January 13, 2009
Recall Status1 Terminated 3 on April 26, 2011
Recall Number Z-0549-2009
Recall Event ID 49510
510(K)Number K050343  
Product Classification Biopsy Forceps - Product Code NLU
Product Biopsy Forceps, Hot
Model #'s:
BAL60110
BAR000852
BAR000854 and
MIC1550
Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, resection, mobilization, and dissection of tissue.
Code Information n/a
Recalling Firm/
Manufacturer		 Sterilmed Inc
11400 73rd Ave N Ste 100
Osseo MN 55369-5562
For Additional Information Contact
763-488-3400
Manufacturer Reason
for Recall		 SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
FDA Determined
Cause 2		 Packaging process control
Action Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.
Quantity in Commerce 126
Distribution AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
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 = NLU and Original Applicant = STERILMED, INC.
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