Z-0278-2023Class II

PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G...

Name: Z-0278-2023 PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G...
Creator: Pajunk Medical Systems, L.P.
Published: 2022-10-10
License: https://open.fda.gov/license/

Pajunk Medical Systems / initiated 2022-10-10 / Terminated / root cause: manufacturing process

FDA source

Pajunk Medical Systems, L.P. began a recall of PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml... on 2022-10-10. FDA classified it as Class II and gives the reason as "The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0278-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-10
Posted: 2022-11-23
Terminated: 2024-01-17
Recalling firm: Pajunk Medical Systems
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.
Product code: OGE Epidural Anesthesia Kit
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,.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued recall letters dated 10/10/2022 via email and overnight mail on 10/10/2022. The letter identified the product, the reason for recall and requested return of the affected lot as soon as possible. A return label was enclosed for return of product. A Customer Acknowledgment form was enclosed for return via email to report the quantity of product being returned. The form also asked the consignee if they remembered any used trays containing the 2ml ampule 0.75% Spinal Marcaine instead of the tray containing a 10ml ampule 0.9% Sodium Chloride. If the answer was yes, the consignee was to report whether the Marcaine was used and were there any adverse outcomes.
Quantity in commerce: 280 trays
Distribution: US Nationwide distribution in the states of CA, NC, TN, PA, and TX.
Product codes and lots: Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859..

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0278-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0278-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23

Product code OGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)