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U.S. Department of Health and Human Services

Class 2 Device Recall Anchor Tissue Retrieval System TRS175SB

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  Class 2 Device Recall Anchor Tissue Retrieval System TRS175SB see related information
Date Initiated by Firm December 09, 2010
Date Posted March 07, 2011
Recall Status1 Terminated 3 on January 20, 2012
Recall Number Z-1591-2011
Recall Event ID 57432
510(K)Number K061555  
Product Classification laparoscope, general & plastic surgery - Product Code GCJ
Product Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS175SB

The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
Code Information Code TRS175SB, lots P36N, P38N, P72N, P77N, P90N, P94N, P98N, Q05N, Q06N, Q11N, Q14N, Q24N, Q26N, Q36N and Q43N
Recalling Firm/
Manufacturer		 Anchor Products Company, Inc.
52 W Official Rd
Addison IL 60101-4519
For Additional Information Contact Mr. Gary S. Thrun
800-323-5134
Manufacturer Reason
for Recall		 The metal component within the unit can break and cause a malfunction. Use of the device may represent a potential health hazard if the metal component is not removed after breakage.
FDA Determined
Cause 2		 Device Design
Action The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.
Quantity in Commerce 2,256 units
Distribution Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom.
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 = GCJ and Original Applicant = ANCHOR PRODUCTS CO.
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