Recall Z-1430-06 ยท HIF Insufflator, Laparoscopic
Richard Wolf Medical Instruments Corp.
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,
| Date | Aug 24, 2006 (initiated Jul 7, 2006) |
| Status | Terminated |
| Reason | The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000180 | TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP Richard Wolf Medical Instruments Corp., Mar 2, 2001 |