UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
- Company
- Neotract Inc
- Recall Initiated
- June 24, 2022
- Posted
- August 5, 2022
- Recall Number
- Z-1502-2022
- Quantity
- 18,722 systems
- Firm Location
- Pleasanton, CA
Reason for Recall
There is the potential that during implant deployment, the device may not properly deliver a implant.
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
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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 uroliftrecall@teleflex.com. 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 uroliftrecall@teleflex.com. 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.