FDA-Device2026-09-16Class IIPACKAGING DEFECT
Windstone Medical AMS Convenience Kit DSAEK Pack recalled for detached infusion port parts
What this means
Windstone Medical Packaging's AMS Convenience Kit DSAEK Pack contains saline solution bags with blue connector pieces that may detach from the infusion port during normal use. This could allow contamination or improper fluid delivery during ophthalmic surgery.
- Stop using affected kits immediately if you have Part Number AMS12394B with lot numbers listed in this recall
- Do not use kits with lot numbers 241907, 241223, 241034, 240904, 240705, 240633, and others through lot 223913
- Contact your supplier or Windstone Medical for replacement kits or instructions
- Report any incidents involving these kits to the FDA MedWatch program
The agency's original wording
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CA, GA, WA.
Affected count
3,260 kits
Manufactured in
1602 4th Ave N, Billings, MT, United States
Products
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3138-2026More Windstone Medical Packaging recalls
- FDA-Device2026-07-08Windstone Medical AMS Preop Kit-NS recalled for bacterial contamination in alcohol prep pads
- FDA-Device2026-07-08A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
- FDA-Device2026-07-08A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
- FDA-Device2026-07-08A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
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