Z-3107-2026 Class I Ongoing
FDA device recall Z-3107-2026 was initiated by Medical Action Industries, Inc. 306 on July 23, 2026 and is designated Class I. Reason for recall: Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility. The recall status is ongoing. Affected quantity: 3,606.
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2026
- Initiation Date
- July 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,606
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
Reason for Recall
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Distribution Pattern
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
Code Information
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)