Z-3106-2026 Class I Ongoing
FDA device recall Z-3106-2026 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: 1,960.
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
- 1,960
Product Description
Kit: Epidural/Pain TQC 20/Cs, REF: 82465 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
UDI-DI: 10809160367414. Lot(Expiration Date): 322200(4/1/2026), 324586(4/1/2026), 327335(4/1/2026), 329618(9/1/2026), 347199(11/1/2026), 337283(11/1/2026), 350354(11/30/2026), 375449(5/31/2027)