PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL1
Summary
The FDA issued a Class II for PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Sof by Pajunk Medical Systems, L.P.. 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,..
Details
Source
Device Recall
External ID
Z-0278-2023
Action Date
2022-11-30
Status
Terminated
Category
device
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.
Lot/Code Info: Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859..
Quantity Affected: 280 trays
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
US Nationwide distribution in the states of CA, NC, TN, PA, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-10
Company
Alpharetta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pajunk Medical Systems, L.P.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pajunk Medical Systems, L.P. have FDA actions?
This is the only FDA action we have on record for Pajunk Medical Systems, L.P. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0278-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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