Cook Inc. Recalls Neff Percutaneous Access Sets Due to Sterility Concerns
Cook Inc. is recalling 97 Neff Percutaneous Access Sets because they may have been manufactured without a bottom seal, compromising sterility. No US distribution occurred.
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 involves a medical device with a compromised sterility seal, which poses a risk of infection (risk-of-harm product). No injuries or illnesses have been reported, and the agency classification is Class II, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cook Inc. is recalling 97 units of the Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT, Lot 8373482. The recall was initiated because the products may have been manufactured without the bottom seal on the outer packaging, which compromises the sterility of the product.
The affected products were not distributed in the United States. According to the recall notice, the products were distributed to China.
Consumers and healthcare providers in the United States are not affected by this recall. Those who may have purchased or received these specific units in foreign markets should contact Cook Inc. for further instructions.
The recalled product
- Product
- Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
- Manufacturer
- Cook Inc.
- Affected units
- 97
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 8373482
Distribution
Distribution scope not specified by the agency.
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