Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
FDA Recall Z-3106-2026 · Posted 2026-09-09
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Recalling FirmMedical Action Industries, Inc. 306
Recall StatusOpen, Classified
Product CodeOGJ
Date Initiated2026-07-23
Product Quantity1,960
Reason for Recall
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Firm Action
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].
Root Cause
Nonconforming Material/Component
Distribution Pattern
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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