FDA Announces Teleflex and Arrow International’s Recall of Mislabeled Pressure Injectable Catheter Kits

The Teleflex and Arrow International Pressure Injectable Catheter Kits allow healthcare providers access to a patient’s central cardiovascular system, which connects the heart and veins. The kits may be used short-term (less than 30 days) for patients with conditions that require frequent injections or blood draws. With the kit, a healthcare provider can sample blood, monitor blood pressure, or administer fluids, medications, or chemotherapy.

The affected products were distributed in the United States from August 30, 2022–June 9, 2023, and are mislabeled regarding the presence of chlorhexidine. The product code and product name are incorrectly listed as noncoated on the lids; however, the banner card correctly lists the product code and product name as chlorohexidine coated.

The following devices and associated product codes are being recalled: 

FDA said that the following groups may be affected:

• People who receive care with the pressure injectable catheter kits
• People with hypersensitivity or allergy to chlorhexidine
• Healthcare professionals who provide care with the ARROW Pressure Injectable Catheter Kits

People who inadvertently use the kits may have serious adverse health effects, including itching, redness, skin changes, hives, dizziness, drop in blood pressure, difficulty breathing, and anaphylaxis (https://medlineplus.gov/ency/article/000844.htm) that could lead to death if they are allergic to chlorohexidine. To date, FDA has received 16 reported incidents associated with the issue but no reports of injuries or deaths. 

On August 10, 2023, Teleflex and Arrow International sent an urgent medical device recall letter to medical facilities and distributors that included the following recommended actions:

For Medical Facilities

• Immediately check inventory for recalled products, stop using and distributing the affected product, and quarantine the affected product.
• Mark the applicable checkbox (affected product or no affected product) on the acknowledgement form included with the letter. Fax the form to 855-419-8507 to Attn: Customer Service or email the form to recalls@teleflex.com (mailto:recalls@teleflex.com). 
  • If you have affected product, a customer service representative will contact you with a return goods authorization number and will provide instructions for the return of affected products to Teleflex. Teleflex (or the local dealer) will issue a credit note upon receipt of the returned affected product.

For Distributors 

• Provide a copy of the urgent medical device recall letter to all customers who have received the affected product. Each customer must complete the acknowledgement form and return it to the distributor.
• Immediately stop use and distribution of, and immediately quarantine, the affected product, then return all product in scope.
• Confirm to Teleflex that the field activities outlined have been completed.
• After completing the actions, forward the completed acknowledgement form to recalls@teleflex.com (mailto:recalls@teleflex.com). Ensure you only list batch numbers in scope of the recall notice when completing the form.
• If the product was distributed outside of the country, notify Teleflex Customer Service.

Customers with questions should contact Teleflex and its subsidiary Arrow International Customer Service by calling 866-396-2111 or emailing recalls@teleflex.com (mailto:recalls@teleflex.com).

Healthcare professionals and consumers may report adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.