Arrow International Recalls SnapLock Catheter/Syringe Adapters Due to Packaging Defect
Arrow International is recalling SnapLock Catheter/Syringe Adapters because unsealed packaging may compromise sterility. The recall affects 416,055 units distributed in the US and 34 other countries.
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 where sterility may be compromised, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 416,055 units of SnapLock Catheter/Syringe Adapters (Product Code: AS-05500). The recall is due to a defect where product sterility may be compromised by unsealed packaging. This issue could potentially lead to the introduction of non-sterile material into a patient's body during medical procedures.
The affected products were distributed nationwide in the United States and in 34 other countries, including Australia, Canada, the United Kingdom, and various nations in Europe, Asia, and the Middle East. The specific lot numbers involved in this recall are 13F17A0065, 13F17B0190, 13F17D0264, 13F17F0246, 13F17F0653, 13F17J0082, and 13F17K0412.
Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected adapters. Consumers or patients who have received these products should contact their healthcare provider or the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
- 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.
See all 76 products in this recall →Related recalls
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