Alpharetta, GA, United States
Pajunk Medical Systems, L.P. recalls
1 recall recorded since 2018, most recently on 10 October 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 October 2022
- Terminated
- 17 January 2024
- 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,.
- Distribution
- US Nationwide distribution in the states of CA, NC, TN, PA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0278-2023
- 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 5
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.