Windstone Medical Packaging, Inc.: Kit, Surgical Instrument, Disposable
Recall Summary Windstone Medical Packaging, Inc. is correcting Convenience Kits that contain Cardinal Health Webcol Large Alcohol Prep Pads manufactured by Aligned Medical Solutions because some of these prep pads are not sterile. The kits were distributed as medical devices and may affect customers who received them.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, GA, WA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f03f269b-74b0-40dc-bc5d-629314d6a187