FDA recall Z-3107-2026

Product

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

US distribution to states of: IA, VA, MO, KS, FL, OH and LS.

Key facts

Status

Ongoing

Initiation date

2026-07-23

Report date

2026-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arden, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3107-2026