Z-1430-06

Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an...

Name: Z-1430-06 Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an...
Creator: Richard Wolf Medical Instruments Corp.
Published: 2006-07-07
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2006-07-07 / Terminated

FDA source

Richard Wolf Medical Instruments Corp. began a recall of 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... on 2006-07-07. The reason FDA records is "The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1430-06
Status: Terminated
Initiated: 2006-07-07
Posted: 2006-08-24
Terminated: 2007-06-15
Recalling firm: Richard Wolf Medical Instruments Corp.
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
Product code: HIF Insufflator, Laparoscopic
Reason for recall: The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
FDA 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 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.
Product codes and lots: Part Number 4170.801, Lot Number 060232

Product code HIF

K000180Class IITransanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set, Instrument Set for the Transanal EndoscopRichard Wolf Medical Instruments Corp. / cleared 2001-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)