Food, drugs, devices › Medical Action Industries Inc
Device recall: PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden,
FDA enforcement event 73237 is a device recall by Medical Action Industries Inc of Arden, NC, initiated 3 Feb 2016 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 28 Jun 2016. Initiation: voluntary: firm initiated. Medical Action Industries Inc has 6 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, Arden, NC.
Reason for recall
"Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling"
Distribution
"Nationwide distribution to MO, NE and TX ."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1036-2016 | PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings | 9 cases (180 kits) | Class II | Terminated | 9 Mar 2016 |
Context
Other enforcement events for Medical Action Industries Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Mar 2019 | Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) | Device | Class II | 1 |
| 27 Nov 2018 | Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 4 | Device | Class II | 1 |
| 11 Dec 2017 | Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This O | Device | Class II | 1 |
| 19 Apr 2017 | White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or | Device | Class II | 2 |
| 12 Jun 2014 | Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC. | Device | Class II | 8 |
All 6 events for Medical Action Industries Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling"
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: "Nationwide distribution to MO, NE and TX ."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Jun 2016. "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.