Class 2 Device Recall Kit, surgical instrument, disposable

• Date Initiated by Firm: December 02, 2019
• Date Posted: January 06, 2020
• Recall Status: Terminated on January 24, 2023
• Recall Number: Z-0779-2020
• Recall Event ID: 84435
• Product Classification: Kit, surgical instrument, disposable - Product Code KDD
• Product: 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
• Code Information: ***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
• Recalling Firm/ Manufacturer: Medical Action Industries, Inc. 306; 25 Heywood Road; Arden NC 28704-9302
• For Additional Information Contact: Marlene Jones; 828-338-7568
• Manufacturer Reason for Recall: The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.
• FDA Determined Cause: Other
• Action: The firm initiated the recall by letter on 12/03/2019. The firm requested distributors apply stickers to the all affected kits in inventory and further notify their customers with a separate letter. End users are requested to discard the affected product.
• Quantity in Commerce: 9924 cases
• Distribution: MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.