Epimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling
Epimed International is recalling 200 Versa-Kath Mini Kits because the labeling incorrectly states a 12-gauge catheter is included, while the kit actually contains a 21-gauge catheter.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding catheter gauge, which is a significant clinical detail but does not involve a direct contamination or structural defect that would typically warrant a higher score without reported injuries.
Plain-English summary
Epimed International, Inc. is recalling 200 units of the Versa-Kath Mini Kit, Reference 181-2112, Lot 311291155. The product is a sterile epidural or caudal anesthesia kit that includes a plastic L.O.R Syringe.
The recall was initiated due to a labeling error. The product labeling states that the kit contains a 12-gauge catheter, but the kit actually contains a 21-gauge catheter. This discrepancy could lead to incorrect clinical use if the labeling is relied upon without verifying the physical device.
The affected products were distributed in the US states of California, Florida, Oklahoma, Arkansas, Washington, Texas, Idaho, and New York, as well as in South Africa and Mexico. Healthcare providers and consumers should check their inventory for this specific lot number and reference number. If found, the product should be removed from use and returned to the distributor or manufacturer per recall instructions.
The recalled product
- Product
- Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia
- Manufacturer
- Epimed International, Inc.
- Category
- Medical Device — Anesthesia Kit
- Hazard
- Affected units
- 200
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 (2)
- Lot 31129155
- Exp: 2022-12-31
Distribution
Part of a larger recall action
This product is one of 2 recalled by Epimed International, Inc. 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, Inc.
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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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