Recall Z-2706-2020 ยท HIF Insufflator, Laparoscopic
Richard Wolf GmbH
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.
| Date | Jul 27, 2020 (initiated Jun 5, 2020) |
| Status | Terminated |
| Reason | Tube material of a smaller diameter was used. |
| Root cause | Process control |
| Action | The firm sent a letter to its consignees on June 5, 2020 indicating their customers the following: Please read this letter as well as the reference documents (see list of appendices) completely and keep them until this measure is completed. Please carry out the following steps: 1. Check your stock for TEM tube sets 4170801 of the lot affected (lot no. 32324159). The sets with the faulty pump tubes shall be blocked for any further use and then discarded and the disposal shall be documented. 2. Make sure within your organization that all users of the product mentioned above and other per-sons t |
| Quantity | 338 sets |
| Distribution | International distribution in the countries of Austria (AT), Canada (CA), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Iceland (IS), Lithuania (LT), Norway (NO), New Zealand (NZ), Sweden (SE), and Netherlands (NL). |
| 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 |