{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222112", "product_res_number": "Z-3138-2026", "event_date_initiated": "2026-07-29", "event_date_posted": "2026-09-10", "recall_status": "Open, Classified", "res_event_number": "99658", "product_code": "KDD", "product_description": "AMS Convenience Kit:\r\nDSAEK Pack - RX, Part Number AMS12394B", "code_info": "UDI-DI:B098AMS12394B0;\nLot 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", "firm_fei_number": "1000125955", "recalling_firm": "Windstone Medical Packaging, Inc.", "address_1": "1602 4th Ave N", "city": "Billings", "state": "MT", "postal_code": "59101-1521", "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.", "root_cause_description": "Equipment maintenance", "action": "An URGENT: MEDICAL DEVICE RECALL notification letter dated 7/29/26 was sent to customers.\n\nAMS requests that you undertake the following activities:\n1. Immediately check your inventory for the recalled products listed above and place them under quarantine.\n2. 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:\nRECALL NOTICE\nBD 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.\n\"At the time the kit is opened for use any BD PHARMACY NACL .9% 100ML BAG should be identified and set aside.\n\"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.\n\n3.Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity.\n4.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.\n5.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.\n6.Indicate on the Recall Reply Form if replacement PHARMACY NACL .9% 100ML BAG are needed.\nPlease 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", "product_quantity": "3,260 kits", "distribution_pattern": "US Nationwide distribution in the states of CA, GA, WA.", "openfda": { "k_number": [ "K821501", "K822158", "K902441", "K874063", "K821502", "K936255", "K920516", "K780336", "K920763", "K971317", "K832628", "K803117", "K914244", "K760051", "K832047", "K831841", "K923176", "K920989", "K771448", "K843206", "K932219", "K761193", "K821500", "K911606", "K813103", "K924958", "K011514", "K880785", "K803199", "K803119", "K850325", "K833075", "K821814", "K870373", "K072814", "K833438", "K925215", "K910366", "K811086", "K802557", "K853910", "K834532", "K780488", "K960456", "K924117", "K770149", "K811855", "K843115", "K871458", "K910369", "K925905", "K830374", "K802017", "K820423", "K831795", "K913049", "K834135", "K910816", "K864969", "K802019", "K803118", "K842627" ], "registration_number": [ 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"device_name": "Kit, Surgical Instrument, Disposable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1" } } ] }