NIPRO Safe Touch Safety Scalp Vein Set Recalled for Potential Cracks
Nipro Medical Corporation is recalling NIPRO Safe Touch Safety Scalp Vein Sets because a crack in the connector could cause fluid leakage.
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, and the hazard involves potential fluid leakage without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Nipro Medical Corporation is recalling 176,000 pieces of NIPRO Safe Touch Safety Scalp Vein Sets. The affected products were distributed worldwide, including in the United States, Canada, and several countries in the Americas.
The recall is due to a possibility of a crack in the CP luer connector at the connection site with the tubing. This crack could cause or contribute to the leakage of fluids. Specific product codes and lot numbers are identified in the official recall notice.
Consumers and healthcare providers should stop using the affected products and contact Nipro Medical Corporation for further instructions or a replacement.
The recalled product
- Product
- NIPRO Safe Touch Safety Scalp Vein Set
- Manufacturer
- Nipro Medical Corporation
- Affected units
- 176,000
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 (8)
- Product Code: PR+25G19
- Lots #s 12H31H and 12I14H
- Product Code: SPR+21G19
- Lots #s 12I24 and 12J11
- Product Code: PR-25G19
- Lot # 12H27H
- and PR-23G19
- Lot # 12I12H.
Distribution
Distribution scope not specified by the agency.
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