FDA Device recall Z-0779-2020
Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSI…
- FDA Device
- Class II
- terminated
- Published 2020-01-15
On 2020-01-15 the FDA classified a Class II recall of Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSI… by Medical Action Industries 306, citing the kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0779-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-02 |
| Published | 2020-01-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medical Action Industries 306 |
| Distribution | AZ, CA, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, OH, PA, RI, SC, TX, VA, WA |
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
Reason
The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.
Identifiers
| code_info | ***CVC*** Clear Sequence Change Kit, REF 77070B Lot Numbers: 0000250140 0000250814 0000251345 0000252860 00002537…***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 000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0779-2020%22
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