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U.S. Department of Health and Human Services

Class 2 Device Recall TEM tube set

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  Class 2 Device Recall TEM tube set see related information
Date Initiated by Firm June 05, 2020
Date Posted July 27, 2020
Recall Status1 Open3, Classified
Recall Number Z-2706-2020
Recall Event ID 85863
510(K)Number K000180  
Product Classification Insufflator, laparoscopic - Product Code HIF
Product 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.
Code Information Lot Number 32324159, Model # 4170.801
Recalling Firm/
Manufacturer		 Richard Wolf GmbH
Pforzheimer Str. 32
Knittlingen Germany
For Additional Information Contact Lisa Williams
847-913-1113
Manufacturer Reason
for Recall		 Tube material of a smaller diameter was used.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HIF and Original Applicant = RICHARD WOLF MEDICAL INSTRUMENTS CORP.
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