Teleflex Medical: Rusch EasyCath Kit

Recall number

Z-2086-2019

Recalling firm

Teleflex Medical

Product

Rusch EasyCath Kit

Status

Terminated

Initiated

2019-07-01

Posted

not on file

Terminated

2021-11-04

Reason

Potential for product not to be sterile.

Root cause

Equipment maintenance

Action

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

Quantity

3,700 devices

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K000070"]

PMA numbers

not on file

Product code

KOD

Firm FEI

3005747797

Firm city

Morrisville

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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