Epimed 15 g R.K. Epidural Needle Recall for Catheter Coating Risk
Epimed International is recalling 576 units of 15 g R.K. Epidural Needles because they may skive a catheter's outer coating, posing a risk of retained catheter fragments.
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 involves a medical device with a risk of harm (retained catheter fragments requiring intervention) where no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Epimed International, Inc. is recalling 576 units of 15 g R.K. Epidural Needles (TW), Catalog #/REF #100-1415. These needles are intended for the epidural placement of anesthetic agents to elicit regional anesthesia. The recall covers three specific lots: Spectra Lot# GC091702, Spectra Lot# GC101871, and Spectra Lot# GC101897.
The recall was initiated because there is a possibility that the needles may skive a catheter's outer coating. If this occurs, a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical intervention. The source text does not report any specific injuries or illnesses associated with this defect.
The affected products were distributed in the United States to the states of Alabama, Alaska, Florida, Indiana, Tennessee, and Texas. Healthcare providers and facilities should check their inventory for the specific lot numbers listed and stop using the affected needles. Patients who have received these needles should contact their healthcare provider if they have concerns.
The recalled product
- Product
- 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
- Manufacturer
- Epimed International, Inc.
- Category
- Medical Device — Needles
- Affected units
- 576
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)
- 1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501
- Sterile Lot # 12157325)
Distribution
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