Medical Devices recall: Cook Medical recalled these Medical Devices

This recall includes all unexpired lots for both of these products.

156
Medical Device recall
Medical Device recall

Last Updated on January 14, 2024 by The Health Master

Cook Medical issued a global, voluntary recall of the following medical devices:

Transseptal Needle
Transseptal Needle with Catheter

This recall includes all unexpired lots for both of these products. The needles (medical device) were recalled due to complaints of rust on the products.

Use of affected medical devices could result in increased procedural time and inflammatory reactions, including systemic reactions which may lead to permanent impairment or death.

The U.S. Food and Drug Administration (USFDA) has not yet classified the recall. A complete list of products affected by this recall can be found below.

Transseptal Needles, including Transseptal Needles with Catheters, were found to have rust internally, externally, or both. To date, Cook Medical has received no reports of injury or illness related to this recall.

Cook has received four complaints where the presence of rust was identified prior to patient contact. However, please be advised that the presence of rust may go undetected by the user. The USFDA and other regulatory agencies around the world have been notified of this action.

Potential adverse events

If an affected product is used, potential negative outcomes include increased procedural time (to obtain a replacement device) and inflammatory reactions ranging from local or self-limited reactions to systemic reactions requiring medical intervention. Systemic reactions could potentially lead to permanent impairment or death.

Affected products

PRODUCT
BRAND NAME
INTENDED USEREFERENCE PART NUMBER (RPN)ORDER NUMBER (GPN)LOT NUMBER / UDIRANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS
Transseptal NeedleIntended for transseptal left heart access in both diagnostic and interventional proceduresTSNC-18-71.0G02364AllOctober 02, 2016 through July 22, 2021
TSNC-19-56.0G02365
Transseptal Needle with CatheterIntended to facilitate transseptal entry into the left atriumTSN-17-75.0-ENDRYSG19261

Recall return information

Customers that received products affected by the recall were sent prepaid labels in a recall information packet. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected products to Cook as soon as possible for credit.

Customers in the U.S. and in Latin America should return affected product(s) to Cook Medical. Before returning affected product to Cook Medical, please obtain an RGA#. You may contact 800.457.4500, press option 5, and enter extension 151090 to obtain an RGA# and return address.

Adverse event reporting

Report adverse events to Cook Medical Customer Relations. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Licensing procedure for Medical devices

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

FAQs on Medical Devices Rules, 2017

FAQs – on Blood Pressure Monitoring Devices

Drug recall: BP medicine recalled due to this reason

Drug recall: Merck recalls Daptomycin for Injection 500mg

Drug recall: Glenmark, Aurobindo recall multiple products

Auro Pharma recalls batches of Drug used to treat severe disease

Drug recall: Granules India and Jubilant recall these Drugs

Drug recall: Dr Reddy’s & Zydus Pharma Recall these drugs

Govt issued notification for Form 29: License to Mfg drugs for…

DCGI nod for device-aided therapy for Parkinson’s patients

Dr Reddy’s to launch Clinical Trials of single dose Sputnik Light…

Serum Institute seeks DCGI Nod for Mfg Covid Vaccine Covovax

These Indian Pharma Cos seek nod from DCGI for marketing Anti…

NFI 2021: Salient features of 6th Edition of National Formulary of India

Indian Pharmacopoeia Commission (IPC)

Govt releases draft policy for R&D, Pharma and Medical Devices

Procedure to obtain license for manufacturing of Homoeopathic Medicines

Latest Notifications regarding Pharmaceuticals

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news