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UroLift System REF UL400-4, QTY 4 Urolfit System with… recallZ-1502-2022 · Neotract Inc · initiated Jun 24, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Neotract Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is the potential that during implant deployment, the device may not properly deliver a implant.

FDA root cause category: Under Investigation by firm

What the company is doing

Between the dates of June 28-29, 2022, NeoTract, Inc. (a subsidiary of Teleflex Inc.) issued a "Urgent Medical Device Recall" notification to affected consignees via UPS. On July 29,2022 NeoTract, Inc. sent an updated recall notification for additional lots that were affected. NeoTract asked consignees to take the following actions: 1. If you have affected stock: a. Immediately discontinue use and quarantine any products with the lot numbers listed above, so that the affected products can be returned to Teleflex. Lot numbers are printed on the product shelf carton and Tyvek labels (refer to attached appendix demonstrating how you can locate the lot numbers and part catalog numbers for these products) b. Please return the affected products as follows as soon as possible: c. Complete the enclosed Recall Acknowledgement Form and email back to [email protected]. This will allow us to document the number of affected products you have on hand for return. A customer service representative will issue you a Return Goods Authorization (RGA) Number and will provide instructions for returning the products to Teleflex. d. Attach the RGA Number to the affected product and follow the shipping instructions provided by Teleflex customer service. 2. If you have no affected stock: a. Please complete the enclosed Recall Acknowledgement Form and email back to [email protected]. This will allow us to document your receipt of this letter. 3. Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service at (866) 396-2111 or may also be reported to the FDA s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, by fax to 1-800-FDA (332)-0178 or by phone, 1- 800-FDA (332)-1088.

Recall details

Recall number
Z-1502-2022
Status
Open, Classified
Initiated by the company
Jun 24, 2022
Posted by the FDA
Aug 5, 2022
Recalling firm
Neotract Inc
Quantity
18,722 systems
Product code
PEW
FDA submissions
K193269
Distribution
US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None

Product description

UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

Code information (models, lots, serial numbers)

UDI/DI: 00814932020049 & 00814932020001; Lot #s: 73M2100393 73A2200670 73M2100394 73A2200671 73M2100395 73A2200672 73A2200012 73A2200673 73A2200013 73A2200674 73A2200014 73A2200832 73A2200221 73A2200841 73A2200222 73A2200859 73A2200223 73A2200905 73A2200224 73B2200116 73A2200225 73B2200466 73A2200226 73C2200567 73A2200473  New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K193269 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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