Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP…
Medical Action Industries, Inc. 306 · Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Open FDA's page for this record- Cfres ID
- 221997
- Product res number
- Z-3107-2026
- Event date initiated
- 2026-07-23
- Event date posted
- 2026-09-09
- Recall status
- Open, Classified
- Res event number
- 99613
- Product code
- OFT
- Product description
- 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
- Firm FEI number
- 1030451
- Recalling firm
- Medical Action Industries, Inc. 306
- Address 1
- 25 Heywood Rd
- City
- Arden
- State
- NC
- Postal code
- 28704-9302
- Reason for recall
- Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 3,606
- Distribution pattern
- US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
- Code info
REF/UDI-DI/Lot(Expiration Date): 59553/10809160010518/330274(9/1/2026), 331036(11/1/2026), 332995(11/1/2026), 333957(11/1/2026), 338894(11/1/2026); 83945B/10809160444269/330827(10/10/2026), 330907(10/10/2026), 333956(11/1/2026), 350340(11/1/2026), 351266(11/30/2026), 373674(5/31/2027)
- 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 GM-OMRA_RECALLS@owens-minor.com Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com If you have any questions, contact Regulatory Affairs Manager at email: GM-OMRA_RECALLS@owens-minor.com.
- Harmonized identifiers (openFDA)
- Device name
- Spinal Epidural Anesthesia Kit
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5120
- Device class
- 2
- Registration number
- 3013764800, 8022210, 1223004, 3004111573, 9616088, 1030451, 1423395, 3004122598, 1423537, 1061927, 1643817, 3007329020, 1061124, 1928237, 3015173212, 3005595283, 3005012805, 3045816907, 2523676, 3006450239, 3035642068, 2521402, 1018470, 3009888344, 3045816902
- FEI number
- 3002902735, 3013764800, 3004111573, 3932, 1030451, 3000203000, 3000717925, 3004122598, 1000120555, 3001236905, 1643817, 3007329020, 1928237, 3015173212, 3005595283, 3005012805, 3045816907, 2523676, 1000512168, 3006450239, 3035642068, 2521402, 1018470, 3009888344, 3045816902