Drug recall
PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G…
FDA recall event 91037 · Class II · Pajunk Medical Systems, L.P.
Key facts
| Event ID | 91037 |
|---|---|
| Recall numbers | Z-0278-2023 |
| Recalling firm | Pajunk Medical Systems, L.P. |
| Product type | Devices |
| Products | 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%… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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,. |
| Initiation date | Oct 10, 2022 |
| Report date | Nov 30, 2022 |
| Termination date | Jan 17, 2024 |
| City | Alpharetta |
| State | GA |
| Country | United States |
| FEI number | 3004076349 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: