Recall Z-0002-2022— Bard Peripheral Vascular Inc

Name: FDA recall Z-0002-2022
Creator: U.S. Food and Drug Administration
Published: 2021-07-27

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2021-07-27. It names one FDA 510(k) clearance: K930217. Product: REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796. Reason: Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-07-27
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K930217 — BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLEBaxter Healthcare Corp·cleared 1994-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.