Arrow International Recalls Spring-Wire Guide Introducer Catheter Assemblies
Arrow International Inc is recalling 416,055 Spring-Wire Guide Introducer Catheter Assemblies because the packaging may be unsealed, potentially compromising product sterility.
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 product is a medical device with Class II classification. The hazard involves compromised sterility due to unsealed packaging, which presents a risk of harm (infection) where injury has not yet been reported. This aligns with the 'risk-of-harm products where injury has not yet been reported' criterion for a High severity score.
Plain-English summary
Arrow International Inc has initiated a recall of its Spring-Wire Guide Introducer Catheter Assembly (Product Code: CN-04018). The company is recalling a total of 416,055 units due to potential packaging defects. Specifically, the product sterility may be compromised because some units were shipped with unsealed packaging.
The recall affects specific lot numbers: 13F17B0039, 13F17C0181, 13F17D0226, 13F17E0065, 13F17E0724, 13F17F0651, 13F17G0531, 13F17H0377, 13F17J0273, 13F17L0216, and 13F17L0218. These products were distributed nationwide in the United States as well as in Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, the Netherlands, New Zealand, Panama, the Philippines, Poland, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and Trinidad and Tobago.
Consumers or healthcare providers who possess these catheter assemblies should stop using them immediately. The unsealed packaging poses a risk that the sterile field of the medical device has been breached. For more information, refer to the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2011-2018.
The recalled product
- Product
- Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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