FDA recall Z-2249-2021

Bard Peripheral Vascular Inc · Class II · device

Product

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.

Distribution

U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan

Key facts

Status
Ongoing
Initiation date
2021-06-23
Report date
2021-08-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2249-2021