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U.S. Department of Health and Human Services

Medical Devices

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Teleflex Incorporated - Arrow International Custom Intravenous (IV) Administration Products (IV Tubing Sets and Accessories) and Certain Arrow Arterial Embolectomy Catheters

Recall Classification: Class I

Date Recall Initiated: February 1, 2010

Product Names:

  • Arrow International Custom Intravenous Administration Products (IV Tubing Sets and Accessories) - ALL LOTS
    • Any Arrow product with a part number beginning with W followed by five numeric digits (such as, W12345)
    • Any Arrow product with a part number beginning with MPI followed by five number digits (such as, MPI-12345) which is an IV tubing set or tubing set accessory
    • Either of the following two part numbers IV-850001-AAMC and IV-85020-UW

To find the complete list of Arrow products affected by this recall, see under Useful Links below.

These products were manufactured from July 1, 2000 through December 31, 2009.

This recall affects products distributed prior to February 19, 2010.

Use:
Intravenous administration tubing sets are used to transfer fluids from a container to a patient’s blood vessel system.

Recalling Firm:
Arrow International, Inc.
2400 Bernville Road
Reading, PA 19605

Reason for Recall:

The company’s testing revealed pin holes or punctures in the sterile Tyvek packaging. Because of these defects, the products may no longer be sterile. This may potentially cause blood-borne or other types of infections, which could result in serious injury or death.

Public Contact:

Customers with questions or to arrange for the return of the affected products are to call the Arrow Custom IV Tubing hotline at 1-866-396-2111, Monday through Friday, 8 a.m. to 8 p.m., Eastern Time.

FDA District:
Philadelphia

FDA Comments:

In February, the company sent their customers a letter directing them to:

  •  STOP using and immediately quarantine the affected products.
  • Return the affected products to the company.
  • Call the Arrow Custom IV Tubing hotline to arrange for product return.

This recall has not caused shortages of any of these products.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links: