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.
- Alaris Pump Model 8100 Infusion Sets
- Lot Numbers: See full list of affected devices in BD recall notice
- Manufacturing Dates: May 1, 2016 to March 31, 2019
- Distribution Dates: July 1, 2016 to April 18, 2019
- Devices Recalled in the U.S.: 151,139,816
- Date Initiated by Firm: May 6, 2019
Becton Dickinson (BD) Alaris Infusion Sets are used with an infusion pump to deliver fluids including medications, blood, or blood products, into a patient's body in a controlled manner. The pump administers fluid via an infusion tubing set into a patient's vein or through other cleared routes of administration. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male Luer with spin lock, and tubing of different lengths. These infusion sets are intended to be used with the BD Alaris Pump Module 8100. The devices are used in hospitals and other health care facilities.
Reason for Recall
Becton Dickinson (BD) is recalling Alaris Infusion Sets, due to the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a "running status." The firm has determined that the silicone segment of the affected administration set has non-uniform thickness. Non-uniform wall thickness can lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing. This device defect may cause serious adverse health consequences for patients, including death. This recall has been associated with MDR reports, several of which are associated with serious injuries.
Who May be Affected
- Hospitals and health care professionals using Alaris Infusion Sets, which include silicone segments to be used with the BD Alaris Pump Module 8100.
- Patients of all ages who may receive fluids, medications, blood, or blood products delivered by a BD Alaris Pump Module 8100 through the Alaris Administration Sets affected by this recall.
What to Do
On May 6, 2019, BD sent customers an Urgent Medical Device Recall informing them of the device models and lot numbers of the Alaris Infusion Sets affected by this recall. On July18, 2019, the Urgent Medical Device Recall was amended, with the following instructions:
- Immediately review your inventory for the specific model codes and lot numbers listed in the Affected Product Table. Destroy all product subject to the recall following your institution's process for destruction.
- Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall.
- Report any case of over-infusion or other serious or unexpected medical device incidents to BD. When reporting, please identify the model code and lot number to aid in the investigation process.
- Complete the attached Customer Response Form and return to the BD contact noted on the form whether you have any of the impacted material or not, so that BD may acknowledge your receipt of this notification and provide product replacement.
- Report any adverse reactions or events experienced with the use of this product to the FDA's MedWatch Program by:
- Web: MedWatch website at www.fda.gov/medwatch
- Phone: 1-800-FDA-1088 Fax: 1-800-FDA-0178
- Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
If you require further assistance, please contact:
|BD Contact||Contact Information||Areas of Support|
|Regional Customer Quality||888-237-2762 OPT 3, OPT 2
Monday - Friday between the hours of 8:00am and 5:00pm (CT)
|Customer Advocacy||Call 888-812-3266 between 7AM-5PM Monday-Friday PST
Adverse Event Reports
- BD Recall for the Alaris Pump Infusion Sets (Initiated May 2019)
- BD Recall for the Alaris Pump Model 8100 (Initiated April 2019)
- BD Provides Update on Voluntary Recalls of Alaris™ Pump Module Model 8100 and Certain Alaris™ Pump Infusion Sets (Issued July 2019)
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience 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.