CLASS II Device recall · Reported 9 Nov 2016 · FDA Enforcement Report
R.K. Epidural Needle (TW) recalled by Epimed International
Epimed International is recalling R.K. Epidural Needle (TW), distributed in Alaska, Alabama, Florida, Indiana, Tennessee, Texas. The recall was initiated on 22 Apr 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0086-2017
- FDA event ID
- 74018
- Recalling firm
- Epimed International, Johnstown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2016
- FDA classified
- 31 Oct 2016
- Reported
- 9 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 22 Apr 2016 | Recall initiated by company | |
| 31 Oct 2016 | Classified by FDA | +192 days |
| 9 Nov 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
Product as listed by the FDA
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
Where it was distributed
US Distribution to the states of : AL, AK, FL, IN, TN & TX
Questions about this recall
Is R.K. Epidural Needle (TW) recalled?
Yes. Epimed International recalled R.K. Epidural Needle (TW) on 22 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-0086-2017.
Why was it recalled?
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
Which lots are affected?
1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)
Where was it sold?
US Distribution to the states of : AL, AK, FL, IN, TN & TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Epimed International
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neo-kath Epidural Catheter Set recalled by Epimed International | Epimed International | Sterility | Nationwide |
| Device | CLASS II | Neo-kath(TM) Caudal Set recalled by Epimed International | Epimed International | Sterility | Nationwide |
| Device | CLASS II | Feth-R-Kath Catheter recalled by Epimed International | Epimed International | Device Malfunction | Nationwide |
| Device | CLASS II | R-F Injector Cannula recalled by Epimed International | Epimed International | Sterility | Nationwide |
| Device | CLASS II | R-F Injector Cannula recalled by Epimed International | Epimed International | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |