DeviceSignal · Recall classified
Windstone Medical Packaging, Inc.
FDA classified a device recall on 2026-09-10 · Class II · Z-3138-2026
EventRecall classified
Effective2026-09-10
ClassificationClass II
On 2026-09-10 the FDA classified a device recall from Windstone Medical Packaging, Inc. as Class II. Product: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B. Recall Z-3138-2026. The firm initiated it on 2026-07-29. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3138-2026
- Classification
- Class II
- Classified on
- 2026-09-10
- Initiated on
- 2026-07-29
- Firm
- Windstone Medical Packaging, Inc.
- Reason
- 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.
- Product
- AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3138-2026- Snapshot hash
e8e634c086f9f5f52e82a7eef6331d8800209bbb8cbb79bd654d29f1222caae4- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-23T12:43:31.676Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
4bb63f4d0e1e05d875e28d864d1de20cf4a9db64ff595abb8b060244db29de63- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)