Arrow Epidural Catheter Kits Recalled Due to Adhesive Manufacturing Defect
Arrow International is recalling FlexTip Plus Epidural Catheter and FlexBlock Continuous Peripheral Nerve Block Catheter Kits due to incorrect manufacturing of liquid adhesive. The recall affects 190 units distributed nationwide.
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: This is an FDA Class II medical device recall. The manufacturing defect (incorrect adhesive) in epidural catheter kits represents a risk-of-harm product involving anesthetic delivery systems, and no reported illnesses or injuries are stated in the source text, making a score of 3 (High) appropriate per the rubric.
Plain-English summary
Arrow International, LLC is recalling FlexTip Plus Epidural Catheter and FlexBlock Continuous Peripheral Nerve Block Catheter Kits (Product Code: ASK-05502-BSM; UDI: (01)10801902209853(17)270831(11)251210(10)33F25K0409; Batch Number: 33F25K0409) due to a supplier notification that the liquid adhesive was incorrectly manufactured. The recall involves 190 units.
These products are intended for epidural anesthesia administration and access to the epidural and subarachnoid spaces. The epidural catheter kit is intended for use up to 72 hours.
The affected products were distributed nationwide to Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, and Virginia. Consumers and healthcare providers who have received these products should contact Arrow International for further instructions regarding this recall.
The recalled product
- Product
- FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural…
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 190
Distribution
Part of a larger recall action
This product is one of 8 recalled by ARROW INTERNATIONAL, LLC 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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