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.
This recall has been terminated (originally issued July 27, 2020).
- Recall Initiated
- June 5, 2020
- Posted
- July 27, 2020
- Terminated
- June 28, 2024
- Recall Number
- Z-2706-2020
- Quantity
- 338 sets
- Official Source
- View on FDA website ↗
Reason for Recall
Tube material of a smaller diameter was used.
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).
Lot / Code Info
Lot Number 32324159, Model # 4170.801
Root Cause
Process control
Action Taken
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 to be informed gain knowledge of this urgent safety information. If the product has been passed on to third parties, please also pass on a copy of this information, and inform the contacts listed below. Make sure that this information is followed in your institution until all necessary in-house measures are completed. 4. To verify receipt of this urgent safety information we need the included answer form which we kindly ask you to return to fax number 07043 351360, or via e-mail to vigilance@richard-wolf.com by June 26, 2020. Please fill in this form even if the product is no longer in your stock. With the answer form you confirm receipt of this urgent safety information and avoid getting further reminder letters from Richard Wolf. 5. Inform Richard Wolf GmbH about any adverse events.