Class 3 Device Recall TEM Disposable Tube Set

• Date Initiated by Firm: July 07, 2006
• Date Posted: August 24, 2006
• Recall Status: Terminated on June 15, 2007
• Recall Number: Z-1430-06
• Recall Event ID: 35845
• 510(K)Number: K000180
• Product Classification: Transanal Endoscopic Microsurgery System insufflation rectal cavity - Product Code HIF
• Product: Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity; Manufacturer: Richard Wolf GmbH, Postfoch 1164, D-75343 Knittlingen, Deutschland; Product Number 4170.801
• Code Information: Part Number 4170.801, Lot Number 060232
• Recalling Firm/ Manufacturer: Richard Wolf Medical Instruments Corp.; 353 Corporate Woods Pkwy; Vernon Hills IL 60061-3110
• For Additional Information Contact: Mr. Robert L. Casarsa; 847-913-1113
• Manufacturer Reason for Recall: The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
• FDA Determined Cause: Other
• Action: Richard Wolf field sales representatives telephoned the end users on 7/7/06, informing them that the blue connectors on the irrigation tube may be reversed in the tube set bundle for lot 060232 only. The end users were requested to return the affected lot of tubes for replacement at no charge, contacting Ms. Ellen Huffman at 800-323-9653, ext. 280 to make arrangements for the exchange of product. Any questions concerning the recall were directed to Ms. Huffman or Robert Casarsa at the same number.
• Quantity in Commerce: 100 sets
• Distribution: Nationwide distribution --- including the states of Alabama, Florida, District of Columbia, Michigan, Minnesota, Nebraska, New York, Ohio, Oregon, Pennsylvania, Utah, Vermont and Wisconsin.
• 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 = HIF