Recall Z-3107-2026 ยท OFT Spinal Epidural Anesthesia Kit
Medical Action Industries, Inc. 306
Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
| Date | Sep 9, 2026 (initiated Jul 23, 2026) |
| Status | Open, Classified |
| Reason | Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility. |
| Root cause | Nonconforming Material/Component |
| 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-print |
| Quantity | 3,606 |
| Distribution | US distribution to states of: IA, VA, MO, KS, FL, OH and LS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.