FDA Device recall Z-0087-2018
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…
- FDA Device
- Class II
- terminated
- Published 2017-11-15
On 2017-11-15 the FDA classified a Class II recall of 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… by Epimed International, citing potential for partially incomplete seal of product, impacting sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0087-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-24 |
| Published | 2017-11-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Epimed International |
| Distribution | AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, WA |
Product
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
Reason
Potential for partially incomplete seal of product, impacting sterility.
Identifiers
| code_info | Lot No. 12168200; Ref No. 107-1416. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0087-2018%22
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