PAJUNK Continuous Epidural Tray Recalled for Wrong Medication in Kit
Pajunk Medical Systems is recalling PAJUNK Continuous Epidural Trays (Model TAL101, Lot 0001359) because some contain 0.75% Marcaine Spinal instead of the intended 0.9% Sodium Chloride. This medication substitution could lead to improper drug administration during epidural procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving substitution of the wrong medication in an epidural anesthesia kit. No illnesses or injuries have been reported, but the misplaced medication presents a risk of improper drug administration during critical epidural procedures.
Plain-English summary
Pajunk Medical Systems, L.P., is recalling PAJUNK Continuous Epidural Trays, Model #TAL101, Lot 0001359, which expire on April 1, 2024. The recall affects 280 sterile trays distributed nationwide in California, North Carolina, Tennessee, Pennsylvania, and Texas. Each tray contains supplies for continuous epidural anesthesia administration: a Tuohy Epidural Needle (17G x 4"), an EpiLong Soft Catheter (19G), and ampules of medication and saline.
The recall was initiated because some affected trays contain an incorrect medication. Specifically, the trays contain a 2ml ampule of 0.75% Marcaine Spinal instead of the intended 10ml ampule of 0.9% Sodium Chloride. This medication substitution could result in improper medication administration during epidural procedures.
Healthcare providers and facilities should identify any trays from this lot in their inventory. Individuals who may have undergone epidural anesthesia procedures using supplies from this recalled lot may wish to consult with their healthcare provider.
The recalled product
- Product
- 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.
- Manufacturer
- Pajunk Medical Systems, L.P.
- Hazard
- medication-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot 0001359
- Exp. date 2024-04-01
- UDI (01) 00858965006007(17)240401(10)0001859..
Distribution
Distributed nationwide across the United States.
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