The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Normal Saline Flush
- Product Description: 12 mL IV Flush Syringe with a 3 mL, 5 mL, or 10 mL fill volume
- Product Codes: All lots of product codes: 1203, 1205, 1210 and 1210-BP
- Manufacturing Dates: September 24, 2015 to August 1, 2016
- Distribution Dates: February 16, 2016 to September 30, 2016
- Devices Recalled in the U.S.: 386,175 syringes nationwide
The normal saline flush is a plastic syringe filled with 0.9% Sodium Chloride. It is used to clear out medical devices that deliver medicine directly into the veins of a patient through a needle or catheter. These syringes are used by health care providers in hospitals or clinics before and after a drip medication is connected to a patent.
Reason for Recall
Nurse Assist Inc. is recalling the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems.
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."
The use of affected products may cause serious adverse health consequences including bloodstream bacterial infections and death.
Who May be Affected
- Health care providers using the normal saline flush syringe
- All patient groups undergoing procedures involving devices that were cleared out by the normal saline flush syringe
What to Do
On October 5, 2016, Nurse Assist, Inc. sent a certified mail notification to all affected customers. The notice asked customers to:
- Immediately discontinue the use of any affected products
- Complete the Medical Device Recall Return response form
- Return any affected products along with the response form to suppliers via the Returned Goods Authorization provided by Nurse Assist, Inc.
- For freight collect shipping information, customers should contact the Customer Service Team at 1-800-649-6800 ext. 10.
Customers with questions are instructed to contact Nurse Assist Inc. by 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.
Date Recall Initiated:
October 4, 2016
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.