NEO-KATH Caudal Catheter Set Recalled Due to Stylet Protrusion Risk
Epimed International is recalling the NEO-KATH Caudal Set (REF 201-2430) because the stylet may protrude from the catheter's tip, potentially causing tissue injury. The recall affects 140 units distributed in the US and internationally.
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 FDA Class II recall involves potential for patient tissue injury from stylet protrusion. No illnesses or injuries are reported, classifying it as a risk-of-harm product without reported injury, which meets the High severity threshold per FDA guidelines.
Plain-English summary
Epimed International is recalling the NEO-KATH Caudal Set, Reference Number 201-2430 (Sterile), because the stylet may protrude from the distal end of the catheter.
A protruding stylet could cause injury to tissue during use or insertion. The recalled product includes 140 units with lot numbers 16308139 (expiration August 2022) and 16308383 (expiration October 2022).
Wide distribution includes the United States (California, Delaware, Ohio, Oklahoma, Pennsylvania, Virginia, Washington, West Virginia), Canada, and Iran.
Patients and healthcare providers with this product should stop using affected units and consult their healthcare provider regarding alternative devices or treatments.
The recalled product
- Product
- NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
- Manufacturer
- Epimed International
- Affected units
- 140
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 (3)
- Reference Number 201-2430
- Lot Numbers 16308139 (Expiration August 2022)
- 16308383 (Expiration October 2022)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Epimed International 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 2 products in this recall →Related recalls
Same manufacturer · Epimed International
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Same hazard · stylet protrusion
See all →- HighNuvectra Recalls Algovita Spinal Cord Stimulation Leads Due to Stylet Protrusion
FDA (Devices) · 2016-12-28
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