# FDA recall Z-0278-2023

> **Pajunk Medical Systems, L.P.** · Class II · device recall initiated 2022-10-10.

## 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,.

## Distribution

US Nationwide distribution in the states of CA, NC, TN, PA, and TX.

## Key facts

- **Recall number:** Z-0278-2023
- **Recalling firm:** Pajunk Medical Systems, L.P.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-10-10
- **Report date:** 2022-11-30
- **Termination date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0278-2023

## Citation

> AI Analytics. FDA recall Z-0278-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0278-2023. Source: US FDA. Licensed CC0.

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