Reported Nov 30, 2022 · Terminated
PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model…
Pajunk Medical Systems, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pajunk Medical Systems, L.P. · 4575 Marconi Drive · Alpharetta, GA · 30005
Is this the product you have?
- 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
200000
- Lot codes and dates
- Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859..
- Amount recalled
- 280 trays
Where it was sold
Why it was recalled
The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.
This product could cause temporary or reversible health problems — stop using it.
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