Recall Z-0779-2020 ยท KDD Kit, Surgical Instrument, Disposable
Medical Action Industries, Inc. 306
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
| Date | Jan 6, 2020 (initiated Dec 2, 2019) |
| Status | Terminated |
| Reason | The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0. |
| Root 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 | 9924 cases |
| Distribution | MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.