FDA Device recall Z-0278-2023
PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each t…
- FDA Device
- Class II
- terminated
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class II recall of PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each t… by Pajunk Medical Systems L P, citing the tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0278-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-10 |
| Published | 2022-11-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Pajunk Medical Systems L P |
| Distribution | US |
Product
PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.
Reason
The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.
Identifiers
| code_info | Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859.. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0278-2023%22
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