Vidacare T.A.L.O.N Intraosseous Needle Recall for Potential Sterility Breach
Vidacare Corporation is recalling T.A.L.O.N intraosseous needles due to a potential breach in sterility. The recall affects 2,104 boxes distributed in the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential breach in sterility for a medical device, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Vidacare Corporation is recalling 2,104 boxes of T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 Needle Sets. The recall is being conducted because of a potential breach in sterility. These are single-use, prescription-only medical devices sterilized with Ethylene Oxide (EO).
The affected products were distributed in the United States to the states of North Carolina, Maryland, Mississippi, Texas, and Missouri, as well as internationally to Canada and Denmark. The recall covers specific lot codes including 3103376, 3103377, 3103378, 3524557, 3547157, 3693167, 3843307, 3868998, 3986753, 3991994, 3991995, 3999583, 4011996, 4023525, 4040723, and 4040724.
Healthcare providers and consumers should stop using the affected needles and contact Vidacare Corporation for further instructions on returning or disposing of the product.
The recalled product
- Product
- T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
- Manufacturer
- Vidacare Corporation
- Affected units
- 2,104
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 3103376
- 3103377
- 3103378
- 3524557
- 3547157
- 3693167
- 3843307
- 3868998
- 3986753
- 3991994
- 3991995
- 3999583
- 4011996
- 4023525
- 4040723
- 4040724
Distribution
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