PAJUNK Continuous Epidural Tray — Class II medical device recall Z-0278-2023
Terminated recall by Pajunk Medical Systems, L.P., reported 2022-11-30, distributed nationwide. The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as in
| Recall number | Z-0278-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pajunk Medical Systems, L.P., Alpharetta, GA, United States |
| Recall initiated | 2022-10-10 |
| Classified | 2022-11-23 |
| Reported by FDA | 2022-11-30 |
| Terminated | 2024-01-17 |
| Distributed | Nationwide (US) |
| Quantity | 280 trays |
| UPC / GTIN / UDI-DI | 00858965006007 |
| Lot numbers | 0001359 |
| Model numbers | TAL101 |
| Expiration dates | 2024-04-01 |
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 for recall
The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0278-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.