Recall record at a glance
| Official record | Z-0002-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Bard Peripheral Vascular Inc. |
| Report date | Oct 13, 2021 |
| Recall initiation date | Jul 27, 2021 |
| Location | Tempe, AZ, United States |
Official product description
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Why the product was recalled
Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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