Recall Z-2249-2021— Bard Peripheral Vascular Inc

Name: FDA recall Z-2249-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-23

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2021-06-23. It names one FDA 510(k) clearance: K930217. Product: TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm. Reason: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-06-23
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

TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm

Reason for recall

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

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