Bard Peripheral Vascular Inc REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.

Recommended Action

Per FDA guidance

On August 4, 2021, Bard Peripheral Vascular, Inc. issued an "Urgent Medical device Correction" notice to affected customers via Fed Ex. In addition to informing consignees about the recall product, BD ask consignees to take the following actions: 1. Please check all inventory locations within your institution for the product listed in Attachment A and immediately destroy all affected product remaining in your possession. The product should have the sterile barrier broken and destroyed per your local facility s destruction process. 2. Share this notice with any users of the product within your facilities to ensure they are also aware of this Urgent Medical Device Correction. 3. If you purchased this product from a distributor, contact your distributor for further instructions. 4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process your credit. 5. Please contact your BD representative to assist in this process or you may also contact the number below for further assistance. 6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 7. BD Contact Information: If you require further assistance please contact: North American Regional Complaint Center, 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted, M-F 8am - 5pm CT, Recall Questions, Product Complaints, Technical Questions