Nurse Assist Initiates Voluntary Recall of IV Flush Syringes

October 4, 2016
FOR IMMEDIATE RELEASE
Contact:
Nurse Assist, Inc.
4409 Haltom Rd.
Haltom City, TX 76117
(800) 649-6800
www.nurseassist.com
Nurse Assist Initiates Nationwide Voluntary Recall of All Unexpired Lots of I.V. Flush Syringes
Haltom City, TX – Nurse Assist, Inc. announced today that it is voluntarily recalling all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia bloodstream infections with the product. According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of Burkholderia cepacia on people “vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.” If a patient is having symptoms, contact your health care provider.
Since patient safety is of utmost importance, all unexpired lots of these products are being recalled until a thorough investigation can be completed. There are no other related recalls for Nurse Assist products.
The recall affects the following lots and part numbers:
Product Code
Product Description
Lot Number
1203
IV Flush Syringe, 3ml fill
All unexpired lots
1205
IV Flush Syringe, 5ml fill
All unexpired lots
1210
IV Flush Syringe, 10ml fill
All unexpired lots
1210-BP
IV Flush Syringe, 10ml fill
All unexpired lots
Product Numbers 1203, 1205, and 1210 are packaged 30 syringes to an inner carton and six inner cartons in a case (180 syringes). For product number 1210-BP, 100 syringes are packaged in an inner carton with four inner cartons in a case (400 syringes). Lot code information can be found on the outer case panel, the back panel of the inner carton, and on each syringe label.

The lots being recalled were distributed to customers and distributors between 02/16/16 and 09/30/16. Product can be identified by the labeling on the packaging and device. Nurse Assist is directing customers not to use the product from recalled lots. Recalled product should be returned for credit by contacting Nurse Assist Customer Service at 1-800-649-6800 ext. 10, Monday through Friday, between the hours of 8am and 5pm, Central Time.
Nurse Assist voluntarily recalled its I.V. Flush Syringes after becoming aware of patients that developed Burkholderia cepacia bloodstream infections while receiving intravenous care using prepackaged saline flushes from Nurse Assist
Nurse Assist is notifying its distributors and customers via email, phone call, and certified mail. Customers will receive instructions for returning product. For freight collect shipping information, please contact the Customer Service Team at 1-800-649-6800 ext. 10.
Nurse Assist is actively investigating the possible link to the infections with the Food and Drug Administration, the U.S. Centers for Disease Control, and various state health departments to ensure that the products are safe for their intended use. Until an investigation can be completed, Nurse Assist urges all healthcare facilities with affected product to discontinue use and return the product to the supplier.
Consumers with questions may contact the company via telephone at 1-800-649-6800 ext. 10, Monday through Friday, between the hours of 8am and 5pm, Central Time. Consumers may also contact the company via email at ProductRemovalInfo@nurseassist.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.


7 Comments

  1. Roberta Rogers

    Where or in what states were these distributed ?

  2. IV Flush Syringe availability update: Several months ago, Nurse Assist was notified that its IV flush syringes were being investigated, along with IV drugs and devices from other manufacturers as a possible source of bacterial infection. Nurse Assist chose the safest course of action and initiated a voluntary recall of certain IV flush product codes. No other Nurse Assist product codes were involved in this voluntary recall. Manufacture and shipment of those product codes resumed earlier this year. IV flush products manufactured by Nurse Assist conform to applicable FDA, ISO and USP standards and are safe and effective for use, along with all other Nurse Assist sterile water and normal saline products.

  3. What healthcare institutions in Pennsylvania were involved with the recall of IV flush products?

    • Please contact the Nurse Assist, Inc. Quality Manager for those details. Brady Kile will be more than glad to assist with any questions you may have. (Please see staff page for contact details)

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