Device recall

Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules

FDA recall source

Recall number

Z-3106-2026

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

OGJ

Device type

Nerve Block Tray

Reason

Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

Root cause

Nonconforming Material/Component

Quantity

1,960

Code info

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)

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