Arrow International Recalls Sheath Adapters Due to Compromised Sterility
Arrow International is recalling Sheath Adapters with Cath-Gard shields because unsealed packaging may compromise 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 recall involves a medical device where sterility may be compromised, posing a risk of infection. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc. is recalling Sheath Adapters with Cath-Gard Catheter Contamination Shields intended for use with 4 - 7 Fr. catheters. The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected products are identified by product code SA-09847 and specific lot numbers: 13F17B0051, 13F17E0713, 13F17F0767, and 13F17J0010. A total of 416,055 units are involved in this recall.
The products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and South America. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
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 Numbers: 13F17B0051 13F17E0713 13F17F0767 13F17J0010
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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