Medical device recalls Moderate risk

Pajunk Medical Systems, L.P. recalls PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL…

Recall date
October 10, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0278-2023
FDA classification
Class II
Brand / firm
Pajunk Medical Systems, L.P.
Sold / distributed
US Nationwide distribution in the states of CA, NC, TN, PA, and TX.

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,.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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