{ "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": "193001", "product_res_number": "Z-1101-2022", "event_date_initiated": "2022-03-21", "event_date_created": "2022-05-17", "recall_status": "Open, Classified", "res_event_number": "89969", "product_code": "KDD", "product_description": "Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: \nPorts Cath Pack (1794)/AMS6569,\nMinor Procedure Pack (20527)/AMS6570B,\nBreast Biopsy Pack (24771)/AMS6572A,\nBone Marrow Pack (11862)/AMS6573,\nUltrasound Biopsy Pack -Rx/AMS6828,\nUltrasound Biopsy Pack -Rx/AMS6828A,\nC Access Tray/AMS9954,\nC Access Tray/AMS9954A,\nAccess Tray A/AMS10234,\nAccess Tray A/AMS10234A,\nC-Access Tray Chicago/AMS10236,\nC-Access Tray Chicago/AMS10236A,\nAccess Tray/AMS10238,\nAccess Tray/AMS10238A,\nAccess Tray/AMS10238B,\nGray Pack/AMS10247,\nGray Pack/AMS10247A,\nC-Access Tray/AMS10249,\nC-Access Tray/AMS10249A,\nC Access Tray/AMS10255,\nC Access Tray/AMS10255A,\nJacksonville Tray/AMS10256,\nJacksonville Tray/AMS10256A,\nJacksonville Tray/AMS10256B,\nNVS Access Tray/AMS10257,\nAZ Access Tray/AMS10271,\nAZ Access Tray/AMS10271A,\nFistulagram/ C-Access Pack/AMS10280,\nFistulagram/ C-Access Pack/AMS10280A,\nUltrasound Tray w/PDI/AMS10710A,\nProcedure Tray/AMS10897A,\nUniversal Block Tray-RX/AMS12381,\nUltrasound Injection-RX/AMS12382,\nPellet Insertion Tray/AMS12735,\nPICC Insertion Tray - RX/AMS-7192CS-8,\nBreast Biopsy Tray/DDS1010G,\nSingle Shot Epidural Tray-Rx/DDS1149,\nPICC Insertion Tray-RX/VYMAXBASIC", "code_info": "AMS6569/ Between 142683 and 170329;\nAMS6570B/ Between 150682 and 170330;\nAMS6572A/Between 150863 and 170779;\nAMS6573/Between 153041 and 167712;\nAMS6828/Between 154460 and 165574;\nAMS6828A/167575, 168392;\nAMS9954/Between 152386 and 157483;\nAMS9954A/Between 157481 and 169200;\nAMS10234/Between 152202 and 159363;\nAMS10234A/Between 158104 and 169113;\nAMS10236/Between 152782 and 156962;\nAMS10236A/Between 157478 and 169198;\nAMS10238/Between 150032 and 160155;\nAMS10238A/Between 159664 and 166692;\nAMS10238B/Between 167164 and 168646;\nAMS10247/Between 146572 and 156705;\nAMS10247A/Between 157182 and 168754;\nAMS10249/Between 158599 and 161959;\nAMS10249A/Between 157256 and 169105;\nAMS10255/Between 150385, and 156000;\nAMS10255A/Between 157201 and 167493;\nAMS10256/153691;\nAMS10256A/Between 158498 and 163451;\nAMS10256B/Between 160447 and 169108;\nAMS10257/Between 158004 and 166979;\nAMS10271/150057;\nAMS10271A/Between 157910 and 168755;\nAMS10280/Between 150046 and 158682;\nAMS10280A/Between 157914 and 168539;\nAMS10710A/Between 154520 and 164202;\nAMS10897A/162161, 163158, 163524;\nAMS12381/Between 154627 and 156334;\nAMS12382/153165;\nAMS12735/164426;\nAMS-7192CS-8/155088, 156610, 156611;\nDDS1010G/153351, 157709, 157746;\nDDS1149/167640;\nVYMAXBASIC/Between 156613 and 165673", "firm_fei_number": "1000125955", "recalling_firm": "Windstone Medical Packaging, Inc.", "address_1": "1602 4th Ave N", "city": "Billings", "state": "MT", "postal_code": "59101-1521", "additional_info_contact": "406-259-6387", "reason_for_recall": "Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.", "root_cause_description": "Nonconforming Material/Component", "action": "On 03/21/22, recall notices were emailed to customers who were informed that only the Prevantics swabs and/or swabsticks contained inside the kits are affected. All other components in the kits are not affected by the recall. The firm asked customers to overlabel affected kits with a label/sticker stating the reason for recall and providing instruction once the kit is opened for use; specifically the affected swab/swabsticks should be set aside, rendered unusable, and disposed of. Customers needing replacement swabs/swabsticks were asked to indicate this on the recall notice response form where they also indicate the number of kits present, which indicates how many labels/stickers are needed to overlabel the kits. Customers who have further distributed affected product were asked to identify their affected customers and notify them of the recall including a copy of the recall notice. All customers were asked to complete and return the response form. Customers with questions or concerns can contact the recalling firm at fieldcorrectiveaction@alignedmedicalsolutions.com", "product_quantity": "53,412", "distribution_pattern": "US: PA, WA, FL, GA", "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": [ "3043620689", "3003528228", "3015859709", "1222773", "9681465", 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Instrument, Disposable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1" } } ] }