Arrow FlexTip Plus Epidural Kit Recalled for Filter Leak
Arrow International is recalling FlexTip Plus Epidural Kits because a rotatable collar on the filter may detach, causing a leak.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices, are classified as Severe (4). The detachment of a filter component causing a leak in an epidural kit represents a significant functional failure.
Plain-English summary
Arrow International Inc. is recalling the Arrow FlexTip Plus Epidural Kit with NRFit Connector. This catheter system is intended for access to the epidural space for the administration of epidural anesthetic and is intended for use up to 72 hours.
The recall was initiated after nine complaints were reported indicating that the rotatable collar on the filter had detached, which caused a leak. The affected product codes include OT19TAGSK, OT19TAGSKA, OT19TAPSK, and OT19TCGLK in the US, and several international codes including AT-05501-NRF, OT19HBPSS, and UM-05400-NRF.
The recall affects 109 units distributed in the US to California, Florida, and Montana, and 23,021 units distributed internationally to Austria, Australia, Germany, Spain, France, Japan, and Singapore. Specific lot numbers are listed in the structured product information. Consumers and healthcare providers should stop using the affected kits and contact Arrow International for further instructions.
The recalled product
- Product
- Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural…
- Manufacturer
- Arrow International Inc
- Hazard
Distribution
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