Class 2 Device Recall AMS Convenience Kit

• Date Initiated by Firm: July 29, 2026
• Date Posted: September 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3138-2026
• Recall Event ID: 99658
• Product Classification: Kit, surgical instrument, disposable - Product Code KDD
• Product: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
• Code Information: UDI-DI:B098AMS12394B0; Lot Numbers: 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444, 237443, 236863, 236740, 236250, 236249, 236111, 235602, 235601, 235442, 235026, 235025, 235024, 235023, 234889, 234839, 234458, 233931, 233930, 233762, 233328, 233224, 231945, 231124, 231123, 231122, 231081, 231080, 230970, 230969, 230968, 230697, 230696, 230695, 230694, 230098, 229977, 229825, 229824, 229656, 229655, 229565, 229390, 229238, 229141, 229140, 228793, 228718, 228572, 228263, 227828, 227540, 227112, 226969, 226897, 226841, 226714, 226572, 226382, 225455, 225276, 225275, 223916, 223915, 223914, 223913
• FEI Number: 1000125955
• Recalling Firm/ Manufacturer: Windstone Medical Packaging, Inc.; 1602 4th Ave N; Billings MT 59101-1521
• Manufacturer 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.
• FDA Determined Cause: Equipment maintenance
• Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 7/29/26 was sent to customers. AMS requests that you undertake the following activities: 1. Immediately check your inventory for the recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack. This sticker will read: RECALL NOTICE BD announced the recall of 70084 PHARMACY NACL .9% 100ML BAG contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. "At the time the kit is opened for use any BD PHARMACY NACL .9% 100ML BAG should be identified and set aside. "The recalled BD PHARMACY NACL .9% 100ML BAG should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. 3.Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity. 4.If you have further distributed this product, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. 5.Please complete the Recall Reply Form within 5 business days and return via email to fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand. 6.Indicate on the Recall Reply Form if replacement PHARMACY NACL .9% 100ML BAG are needed. Please complete the attached AMS Recall Reply Form and return it to Aligned Medical Solutions at the Fax number provided on the form. If you do not have the affected product, you must complete and return the AMS Recall Reply Form. Replacement BD Fresenius Kabi Freeflex IV Container contained within the kit will be issued upon request and completion of the attached Recal
• Quantity in Commerce: 3,260 kits
• Distribution: US Nationwide distribution in the states of CA, GA, WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.