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Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium… recallZ-3106-2026 · Medical Action Industries, Inc. 306 · initiated Jul 23, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medical Action Industries, Inc. 306 or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 7/23/2026, "Urgent: Medical Device Recall" notices were emailed to customers who were asked to do the following: 1) Identify, Segregate, and Quarantine all impacted kits. 2) Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative. 3) REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use. 4) Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5) Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 6) Complete and return the Recall Response Form via email to [email protected] Report any quality problems or adverse events associated with the products listed in this notification to [email protected] If you have any questions, contact Regulatory Affairs Manager at email: [email protected].

Recall details

Recall number
Z-3106-2026
Status
Open, Classified
Initiated by the company
Jul 23, 2026
Posted by the FDA
Sep 9, 2026
Recalling firm
Medical Action Industries, Inc. 306
Quantity
1,960
Product code
OGJ
Distribution
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.

Product description

Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules

Code information (models, lots, serial numbers)

UDI-DI: 10809160367414. Lot(Expiration Date): 322200(4/1/2026), 324586(4/1/2026), 327335(4/1/2026), 329618(9/1/2026), 347199(11/1/2026), 337283(11/1/2026), 350354(11/30/2026), 375449(5/31/2027)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99613).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page