NEO-KATH Epidural Catheter Set recalled for potential stylet protrusion
Epimed International recalls NEO-KATH Epidural Catheter Set (Lot 16308275, 16308382) due to potential stylet protrusion from the catheter distal end, which poses injury risk during epidural procedures.
What this means for you
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 for a potential stylet protrusion defect in an epidural catheter. No illnesses or injuries are reported in the source text. As a risk-of-harm product without reported injury, this warrants a High severity classification per the rubric.
Plain-English summary
Epimed International is recalling the NEO-KATH Epidural Catheter Set, Reference Number 200-2430, Sterile. The recall affects 132 units distributed worldwide. Lot Numbers 16308275 (expiration August 2022) and 16308382 (expiration October 2022) are included in this recall.
There is a potential for the stylet to protrude from the distal end of the catheter. This defect could result in patient injury during epidural injection procedures.
In the United States, affected product was distributed to California, Delaware, Ohio, Oklahoma, Pennsylvania, Virginia, Washington, and West Virginia. International distribution includes Canada and Iran.
Healthcare facilities and practitioners who have affected units should discontinue use and contact Epimed International for replacement or further instructions.
The recalled product
- Product
- NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
- Manufacturer
- Epimed International
- Hazard
- stylet-protrusion
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 200-2430
- Lot Numbers 16308275 (Expiration August 2022)
- 16308382 (Expiration October 2022)
Distribution
Distributed in 8 states:
- CA
- DE
- OH
- OK
- PA
- VA
- WA
- WV
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