{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Arden", "state": "NC", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "84435", "recalling_firm": "Medical Action Industries, Inc. 306", "address_1": "25 Heywood Road", "address_2": "N/A", "postal_code": "28704-9302", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, WA", "recall_number": "Z-0779-2020", "product_description": "Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B ***PICC*** Clear Sequence Change Kit, REF 77069B Adult Central Line Dressing Change Kit, REF 74636C Central Line Dressing Kit, VCU, REF 57647B Central Line Removal Kit, REF 78631B Chest Tube Cleaning Kit, REF 73000 CVC Dressing Change Kit, REF 80643D Dressing Change Kit, REF 71538 ED Suture Set, REF 59299C Laceration Kit, REF 59806B Laceration Tray, REF 56957 Laceration Tray, REF 57888B Laceration Tray, REF 59387 Laceration Tray, REF 59387B Laceration Tray, REF 69477B Laceration Tray, REF 71582 LACERATION/SUTURE REMOVAL, REF 72347 LACERATION/SUTURE REMOVAL, REF 72347B Pediatric Central Line Dressing Kit, REF 74635C PICC Central Line Dressing Kit VCU, REF 59589C PICC/CVC/Central /Dialysis Clear Sequence Dressing Kit, REF 78197 Suture Kit, REF 59836 Trach Care Kit, Kit de Traqueostomia, REF LH_68162B Trach Care Tray, REF 56791B Trach Care Tray, REF 75378 Tracheostomy Care Tray, REF 4129 Tracheostomy Tray, REF 80209 Wound Care Kit, REF 68330 Wound Care Tray, REF 68358 MEDICHOICE: Tracheostomy Kit, Reorder: TRAC1002 THERAPY SUPPLY HOUSE: VAD DRESSING CHANGE KIT, Reorder # 76512B", "product_quantity": "9924 cases", "reason_for_recall": "The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.", "recall_initiation_date": "20191202", "center_classification_date": "20200106", "termination_date": "20230124", "report_date": "20200115", "code_info": "***CVC*** Clear Sequence Change Kit, REF 77070B Lot Numbers: 0000250140 0000250814 0000251345 0000252860 0000253786 0000254661 0000255539 0000256372 0000256478 0000256896 0000257916 0000259710 0000260807 0000261950 0000262411 0000262853 0000263255 0000248930 0000248004 0000245391 ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B Lot Numbers: 0000255949 0000256795 0000258076 0000260410 0000261183 0000262656 0000257187 ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B Lot Numbers: 0000261186 0000261949 0000263402 0000245684 ***PICC*** Clear Sequence Change Kit, REF 77069B Lot Numbers: 0000250126 0000250752 0000251646 0000252449 0000255455 0000256371 0000256796 0000256897 0000257625 0000258163 0000260908 0000262404 0000262852 0000249190 0000248773 Adult Central Line Dressing Change Kit, REF 74636C Lot Numbers: 0000250172 0000251684 0000251775 0000252730 0000255062 0000255669 0000256289 0000257970 0000259210 0000259867 0000260734 0000263279 0000264415 0000248260 Central Line Dressing Kit, VCU, REF 57647B Lot Numbers: 0000249224 0000248261 Central Line Removal Kit, REF 78631B Lot Numbers: 0000258405 0000264395 Chest Tube Cleaning Kit, REF 73000 Lot Numbers: 0000254875 0000256642 0000257028 0000261394 0000248107 0000247565 0000246033 0000244487 CVC Dressing Change Kit, REF 80643D Lot Numbers: 0000263867 Dressing Change Kit, REF 71538 Lot Numbers: 256205 0000256888 ED Suture Set, REF 59299C Lot Numbers: 0000250820 0000252658 0000254734 0000255276 0000257072 0000260553 0000262731 Laceration Kit, REF 59806B Lot Numbers: 0000250817 0000252940 0000253601 Laceration Tray, REF 56957 Lot Numbers: 0000255242 0000257303 0000258844 0000260451 0000263359 Laceration Tray, REF 57888B Lot Numbers: 0000255947 0000257545 0000257931 0000259064 0000260150 0000261007 0000262982 0000263363 Laceration Tray, REF 59387 Lot Numbers: 0000248176 0000247839 Laceration Tray, REF 59387B Lot Numbers: 0000255606 0000256080 0000256505 0000259051 0000259659 0000260338 0000261192 0000262714 0000263075 Laceration Tray, REF 69477B Lot Numbers: 0000256510 0000261832 0000263335 Laceration Tray, REF 71582 Lot Numbers: 0000250813 0000252624 0000248502 LACERATION/SUTURE REMOVAL, REF 72347 Lot Numbers: 0000250772 0000248306 LACERATION/SUTURE REMOVAL, REF 72347B Lot Numbers: 0000256124 0000258422 0000259257 0000260325 0000261864 0000263377 0000263889 Pediatric Central Line Dressing Kit, REF 74635C Lot Numbers: 0000254205 0000255191 0000258646 0000259884 0000263819 0000249687 0000248262 PICC Central Line Dressing Kit VCU, REF 59589C Lot Numbers: 0000251690 0000252258 0000248259 PICC/CVC/Central /Dialysis Clear Sequence Dressing Kit, REF 78197 Lot Numbers: 0000262582 0000263685 Suture Kit, REF 59836 Lot Numbers: 0000250818 0000252923 0000253808 0000254794 0000258842 0000260452 0000263353 Trach Care Kit, Kit de Traqueostomia, REF LH_68162B Lot Numbers: 0000256422 0000258614 Trach Care Tray, REF 56791B Lot Numbers: 0000252599 0000252842 0000253529 0000255449 0000257898 0000258435 0000263562 0000257350 Trach Care Tray, REF 75378 Lot Numbers: 0000250819 0000252601 0000255861 0000257905 0000259371 Tracheostomy Care Tray, REF 4129 Lot Numbers: 0000253196 0000254514 0000255528 0000256340 0000258894 0000261328 Tracheostomy Tray, REF 80209 Lot Numbers: 0000253370 0000256337 0000257128 0000257903 0000258437 0000259368 0000262397 Wound Care Kit, REF 68330 Lot Numbers: 0000254655 0000255948 0000257266 0000257856 0000259029 0000259816 0000261467 0000263582 Wound Care Tray, REF 68358 Lot Numbers: 0000255446 0000257267 0000259030 0000259817 0000264334 MEDICHOICE: Tracheostomy Kit, Reorder: TRAC1002 Lot Numbers: 0000253474 0000255267 0000256338 0000259025 0000259351 0000262396 0000263581 THERAPY SUPPLY HOUSE: VAD DRESSING CHANGE KIT, Reorder # 76512B Lot Numbers: 0000252929 0000254713" } ] }