Recalls / —

—#174360

Product

Rusch EasyCath Kit

FDA product code

KOD — Catheter, Urological

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K000070

Affected lot / code info

Catalog Number ECK120, Lot Number 74C1900304, Expiration Date 03/01/2022. Catalog Number ECK125, Lot Number 74B1901676, Expiration Date 06/01/2022.

Why it was recalled

Potential for product not to be sterile.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Teleflex Medical notified customers on about 07/01/2019 via "Urgent Medical Device Recall Notification" letter. Distributors were instructed to: 1. Immediately discontinue distribution and quarantine any affected products. 2. Communicate this recall to any of your customers who have received product included within the scope of the recall using the provided customer letter. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. 4. To return recalled products to Teleflex Medical, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. A customerservice representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 5. Once you have completed returning all of the recalled products from your own inventory and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. 6. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Risk Managers were instructed to: 1. Immediately discontinue use and quarantine any affected products. 2. Complete and return the enclosed Recall Acknowledgement Form 3. Once the Recall Acknowledgement Form is received, instructions will be provided on how to return any affected product directly to your distributor. 4. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to your distributor. For questions, contact your local sales repr

Recalling firm

Firm

Teleflex Medical

Address

3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern

Nationwide distribution to CA, FL, IL, NC, NJ, OH, OK, TX.

Timeline

Recall initiated

2019-07-01

Terminated

2021-11-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #174360. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.