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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 setsee related information
Date Initiated by FirmJune 05, 2020
Date PostedJuly 27, 2020
Recall Status1 Terminated 3 on June 28, 2024
Recall NumberZ-2706-2020
Recall Event ID 85863
510(K)NumberK000180 
Product Classification Insufflator, laparoscopic - Product Code HIF
ProductTube 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
FEI Number 3002808001
Recalling Firm/
Manufacturer		 Richard Wolf GmbH
Pforzheimer Str. 32
Knittlingen Germany
For Additional Information ContactLisa Williams
847-913-1113
Manufacturer Reason
for Recall		Tube material of a smaller diameter was used.
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce338 sets
DistributionInternational 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 CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = HIF
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