Device 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.
Z-0278-2023
Product summary
- Event
- Event 91037
- Status
- Terminated
- Classification
- Class II
- Quantity
- 280 trays
- Official record key
device-enforcement:Z-0278-2023
Official wording
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,.
Code information: Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859..
Distribution pattern: US Nationwide distribution in the states of CA, NC, TN, PA, and TX.
Derived failure modes
-
Unknown
The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.