CLASS II Device recall · Reported 15 Nov 2017 · FDA Enforcement Report
RX-2 Coude Epidural NeedleTW, Calibrated, Plastic Hub recalled
Epimed International is recalling RX-2 Coude Epidural NeedleTW, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, distributed in 13 states. The recall was initiated on 24 Jul 2017 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-0087-2018
- FDA event ID
- 77842
- Recalling firm
- Epimed International, Farmers Branch, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2017
- FDA classified
- 9 Nov 2017
- Reported
- 15 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 24 Jul 2017 | Recall initiated by company | |
| 9 Nov 2017 | Classified by FDA | +108 days |
| 15 Nov 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for partially incomplete seal of product, impacting sterility.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
Where it was distributed
Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
ArkansasCaliforniaIowaIndianaKentuckyLouisianaMichiganNew YorkOhioOregonTennesseeTexasWashington
Questions about this recall
Is RX-2 Coude Epidural NeedleTW, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet recalled?
Yes. Epimed International recalled RX-2 Coude Epidural NeedleTW, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet on 24 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0087-2018.
Why was it recalled?
Potential for partially incomplete seal of product, impacting sterility.
Which lots are affected?
Lot No. 12168200; Ref No. 107-1416.
Where was it sold?
Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
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
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |