FDA recall Z-0002-2022

Product

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.

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, Asia, South Africa, Canada, JAPAN, India, Hong Kong, New Zealand, Mexico, China, Belgium, Malaysia, Singapore, Vietnam.

Key facts

Status

Ongoing

Initiation date

2021-07-27

Report date

2021-10-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2022