CLASS II Device recall · Reported 30 Nov 2022 · FDA Enforcement Report
Pajunk Continuous Epidural Tray, Tuohy Epidural Needle recalled
Pajunk Medical Systems is recalling Pajunk Continuous Epidural Tray, Tuohy Epidural Needle with EpiLong Soft Catheter, Closed, distributed nationwide in the US. The recall was initiated on 10 Oct 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0278-2023
- FDA event ID
- 91037
- Recalling firm
- Pajunk Medical Systems, Alpharetta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2022
- FDA classified
- 23 Nov 2022
- Reported
- 30 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 10 Oct 2022 | Recall initiated by company | |
| 23 Nov 2022 | Classified by FDA | +44 days |
| 30 Nov 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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,.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of CA, NC, TN, PA, and TX.
Nationwide CaliforniaNorth CarolinaPennsylvaniaTennesseeTexas
Questions about this recall
Is Pajunk Continuous Epidural Tray, Tuohy Epidural Needle with EpiLong Soft Catheter, Closed recalled?
Yes. Pajunk Medical Systems recalled Pajunk Continuous Epidural Tray, Tuohy Epidural Needle with EpiLong Soft Catheter, Closed on 10 Oct 2022. The recall is Class II and its status is Terminated. Recall number Z-0278-2023.
Why was it 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,.
Which lots are affected?
Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859..
Where was it sold?
US Nationwide distribution in the states of CA, NC, TN, PA, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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