Nipro Safe Touch TULIP Safety Fistula Needle Packaging Error Recall
Nipro Medical Corporation is recalling 50,000 fistula needles because some 1 1/4-inch needles were packaged in 1-inch blister packs.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a packaging/labeling error rather than a direct contamination or structural failure, fitting the Moderate severity criteria for minor labeling errors or precautionary recalls.
Plain-English summary
Nipro Medical Corporation is recalling 50,000 pieces of Nipro Safe Touch TULIP Safety Fistula Needles, model FT+152530TP, Lot # 15C03. These needles are used as blood access devices for blood purification and other treatments requiring an extracorporeal circuit of larger volumes of blood.
The recall was initiated because some 1 1/4-inch needles were packaged and labeled in 1-inch blister packages. This packaging discrepancy could lead to the use of the wrong needle size for a specific medical procedure.
The affected products were distributed in Indiana. Users of these medical devices should stop using the recalled needles and contact Nipro Medical Corporation for further instructions or replacement.
The recalled product
- Product
- Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
- Manufacturer
- Nipro Medical Corporation
- Category
- Medical Device — Needles
- Affected units
- 50,000
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 (1)
- Lot # 15C03
Distribution
Distributed in 1 state:
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