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FDA-Device2021-10-13Class IIPROCESSING DEFECT

Bard TIN3015 bone marrow aspiration needle recalled for dislodging needle protector

Bard
Nationwide distribution

Stop using Bard TIN3015 aspiration needles

The needle protector on Bard's TIN3015 bone marrow aspiration/intraosseous infusion needles can become fully dislodged during use, exposing the needle and creating a needlestick hazard for healthcare workers. This affects numerous lot numbers distributed nationwide from June 2021 through May 2026.

  • Check your supply for affected lot numbers (expiration dates June 2021 through May 2026)
  • Stop using any needles from the recalled lots immediately
  • Quarantine or destroy recalled inventory per your facility's procedures
  • Contact Bard Peripheral Vascular Inc. for guidance on replacement stock
Hazard

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

Sold states
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.
Manufactured in
1625 W 3rd St Bldg 1, Tempe, AZ, United States
Products
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Official notice

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

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