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.