Food, drugs, devices › Medical Action Industries, Inc. 306
Device recall: Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, RE
FDA enforcement event 84435 is a device recall by Medical Action Industries, Inc. 306 of Arden, NC, initiated 2 Dec 2019 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 24 Jan 2023. Initiation: voluntary: firm initiated. Medical Action Industries, Inc. 306 has 15 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medical Action Industries, Inc. 306, Arden, NC.
Reason for recall
"The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0."
Distribution
"MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, WA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0779-2020 | 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… | 9924 cases | Class II | Terminated | 15 Jan 2020 |
Context
Other enforcement events for Medical Action Industries, Inc. 306
All 15 events for Medical Action Industries, Inc. 306
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, WA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Jan 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.