Recall Z-0278-2023— Pajunk Medical Systems, L.P.
Class II · Terminated
Class II FDA medical device recall by Pajunk Medical Systems, L.P., initiated 2022-10-10, terminated 2024-01-17. FDA's recall record names no specific 510(k) clearance for this event. 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,..
- Recalling firm
- Pajunk Medical Systems, L.P.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-10-10
- Terminated
- 2024-01-17
- Firm location
- Alpharetta, GA, United States
Product description
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,.
Data sourced from openFDA. This site is unofficial and independent of the FDA.