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.
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 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
- Hazard
- stylet-protrusion
- tissue-injury-risk
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
Distributed in 8 states:
- CA
- DE
- OH
- OK
- PA
- VA
- WA
- WV
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