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
FDA Recall Z-1430-06 · Posted 2006-08-24
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Recalling FirmRichard Wolf Medical Instruments Corp.
Recall StatusTerminated
Product CodeHIF
Date Initiated2006-07-07
Date Terminated2007-06-15
Product Quantity100 sets
Reason for Recall
The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide distribution --- including the states of Alabama, Florida, District of Columbia, Michigan, Minnesota, Nebraska, New York, Ohio, Oregon, Pennsylvania, Utah, Vermont and Wisconsin.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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