Epimed Feth-R-Kath Catheter Recalled for Coating Deterioration
Epimed International is recalling Feth-R-Kath Catheters because the outer coating may crack or flake off. The recall covers 5,835 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: The recall is classified as FDA Class II, and the hazard involves a medical device defect (coating flaking) that poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Epimed International, Inc. is recalling 5,835 units of the Feth-R-Kath Catheter, 19g x 24" (Catalog # 157-1924). The product is a radiolucent opaque epidural catheter intended for epidural anesthesia and is limited to placement of 72 hours or less.
The recall was initiated because the outer coating of the catheter may deteriorate, resulting in the coating cracking and/or potentially flaking off. The affected lot numbers are 11247915, 11248510, 11248553, 11248938, 11248985, and 11249049.
The product was distributed nationwide in the United States. Healthcare providers and facilities should stop using the affected units and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
- Manufacturer
- Epimed International, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 5,835
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 (6)
- Lot Numbers: 11247915
- 11248510
- 11248553
- 11248938
- 11248985
- 11249049
Distribution
Distributed nationwide across the United States.
Related recalls
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- HighEpimed 15 g R.K. Epidural Needle Recall for Catheter Coating Risk
FDA (Devices) · 2016-11-09
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