Recall Z-0002-2022 ยท FMI Needle, Hypodermic, Single Lumen
Bard Peripheral Vascular Inc
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
| Date | Jul 27, 2021 |
| Status | Open, Classified |
| Reason | Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick. |
| Root cause | Packaging change control |
| Action | 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 yo |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV and the countries of Netherlands, United Arab Emirates, Australia, Taiwan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930217 | BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE Baxter Healthcare Corp, Feb 28, 1994 |