FDA recall Z-3138-2026

Product

AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B

Reason for recall

The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.

Distribution

US Nationwide distribution in the states of CA, GA, WA.

Key facts

Status

Ongoing

Initiation date

2026-07-29

Report date

2026-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billings, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3138-2026