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Audience: Hospital risk managers
Teleflex Incorporated notified healthcare professionals of the recall of all lots of Arrow Select IV Tubing Sets, accessories, and certain lots of arterial embolectomy catheters because it has been determined that product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged, and if product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death.
Consumers who have products with the part numbers notice in the firm's press release should stop using and return the items to Arrow International. Customers can find the entire affected product list at www.teleflexmedical.com.
Read the MedWatch safety summary, including a link to the firm's Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
