Device recall
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
- Recall number
- Z-3107-2026
- Event id
- 99613
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- Medical Action Industries, Inc. 306
- Report date
- Sep 16, 2026
- Posted
- Sep 9, 2026
- Initiated
- Jul 23, 2026
- Center classification date
- Sep 9, 2026
- Product code
- OFT
- Device type
- Spinal Epidural Anesthesia Kit
- Reason
- Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
- Root cause
- Nonconforming Material/Component
- Quantity
- 3,606
- 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)
- Distribution
- US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Arden, NC, United States