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Medical Device

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

Recall date: 2026-09-16 · Source: FDA_DEVICE
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.
Units affected
3,260 kits
Description
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
View official recall notice →