Arrow International Recalls FlexTip Plus Epidural Catheterization Sets
Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.
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 risk of harm (dural puncture) where specific injury counts are not reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Epidural Catheterization Sets, Product Code JC-05400-DCS. The recall involves 343,105 units distributed to 38 U.S. states. The specific lot numbers are listed in the source metadata.
The recall was initiated because the loss of resistance (LOR) syringes included in the kits have the potential for various failures. These failures may result in dural puncture, with some instances requiring a blood patch.
Healthcare providers and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
- Manufacturer
- Arrow International Inc
- Affected units
- 343,105
Distribution
Part of a larger recall action
This product is one of 49 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 49 products in this recall →Related recalls
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Same hazard · dural puncture
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FDA (Devices) · 2020-02-19
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Similar recalls
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