Z-0278-2023 Class II Terminated
FDA device recall Z-0278-2023 was initiated by Pajunk Medical Systems, L.P. on October 10, 2022 and is designated Class II. 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,. The recall status is terminated (terminated January 17, 2024). Affected quantity: 280 trays.
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2022
- Initiation Date
- October 10, 2022
- Termination Date
- January 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280 trays
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,.
Distribution Pattern
US Nationwide distribution in the states of CA, NC, TN, PA, and TX.
Code Information
Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859..