Medical Action Industries, Inc. 306
Arden, NC, US
MEDICAL ACTION INDUSTRIES, INC. 306 appears in FDA device records in Arden, NC. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 39 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Medical Action Industries, Inc. 306 carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medical Action Industries, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 8 510(k) clearances for Medical Action Industries, Inc. 306 between 1981 and 2005. The busiest year on record is 1981, with 2. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1988 | 1 |
| 1992 | 1 |
| 1995 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042526 | DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX | KKX | Substantially Equivalent | |
| K042527 | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 | HHT | Substantially Equivalent | |
| K022948 | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L | HIB | Substantially Equivalent | |
| K946019 | SURGICLA INSTRUMENT KIT | FRG | Substantially Equivalent | |
| K923846 | BURN DRESSING | NAB | Substantially Equivalent | |
| K884826 | GAUZE SPONGE | EFQ | Substantially Equivalent | |
| K810685 | SUTURE REMOVAL KIT | GEN | Substantially Equivalent | |
| K810184 | LAPAROTOMY SPONGE | GDY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1030451 | 1030451 | MEDICAL ACTION INDUSTRIES, INC. 306 | 25 HEYWOOD RD., ARDEN, NC 28704 US | 2026 | and 115 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAZAnesthesia Conduction Kit
- HRXArthroscope
- ITGBandage, Cast
- FQMBandage, Elastic
- FNYBasin, Emesis
- LWEBone Marrow Collection/Transfusion Kit
- HFXClamp, Circumcision
- GDJClamp, Surgical, General & Plastic Surgery
- HFWClamp, Umbilical
- KDTContainer, Specimen Mailer And Storage, Sterile
- LWHCounter, Sponge, Surgical
- IPMCover, Limb
- MACDecontamination Kit
- KKXDrape, Surgical, Antimicrobial
- DRXElectrode, Electrocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FRLFiber, Medical, Absorbent
- GENForceps, General & Plastic Surgery
- HNRForceps, Ophthalmic
- EFQGauze/Sponge, Internal
- GDYGauze/Sponge, Internal, X-Ray Detectable
- LROGeneral Surgery Tray
- FYAGown, Surgical
- LRSI.V. Start Kit
- MDMInstrument, Manual, Surgical, General Use
- KDCInstrument, Surgical, Disposable
- KDDKit, Surgical Instrument, Disposable
- LYVLabel Or Tag, Sterile
- FDELaparoscopy Kit
- FTALight, Surgical, Accessories
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FMINeedle, Hypodermic, Single Lumen
- HRPPen, Marking, Surgical
- FTNPlastic Surgery And Accessories Kit
- FMPProtector, Skin Pressure
- FFORetractor, Self-Retaining
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- LRWScissors, General, Surgical
- FPASet, Administration, Intravascular
- HHTSpatula, Cervical, Cytological
- HDFSpeculum, Vaginal, Metal
- HIBSpeculum, Vaginal, Nonmetal
- FQLStocking, Medical Support (For General Medical Purposes)
- FMGStopcock, I.V. Set
- MCZSuture Removal Kit
- KYZSyringe, Irrigating (Non Dental)
- LJHSystem, Irrigation, Urological
- KGXTape And Bandage, Adhesive
- FTYTape, Measuring, Rulers And Calipers
- GAXTourniquet, Nonpneumatic
- FCHTray, Biopsy, Without Biopsy Instruments
- FKGTray, Start/Stop (Including Contents), Dialysis
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- KNTTubes, Gastrointestinal (And Accessories)
- GAZTubing, Noninvasive
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter
- DQXWire, Guide, Catheter
- MCYWound Dressing Kit
- FRGWrap, Sterilization
Recall records
Showing 25 of 39| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2858-2026 | Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791 | Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal. | Class II | Open, Classified | |
| Z-2792-2026 | Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds | Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels. | Class I | Open, Classified | |
| Z-2007-2026 | Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case | Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold" | Class I | Open, Classified | |
| Z-3129-2024 | Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350 each/case), 6830 (8 rolls/case), and 6860 (8 rolls/case) | The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN. | Class II | Open, Classified | |
| Z-1394-2024 | IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile. | The kits contain saline flush syringes which were recalled by the supplier. | Class II | Open, Classified | |
| Z-0751-2023 | Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit | XXX | Class II | Terminated | |
| Z-0765-2023 | Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile. | Scissors contained debris. | Class II | Terminated | |
| Z-0464-2023 | Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit. | The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits. | Class II | Terminated | |
| Z-0265-2023 | B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022) | The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024. | Class II | Terminated | |
| Z-0147-2022 | Kit: Central Line Dres Change 20/Cs | The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date. | Class II | Terminated | |
| Z-1949-2021 | Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits | Class II | Terminated | |
| Z-1948-2021 | Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits | Class II | Terminated | |
| Z-1947-2021 | novaplus, General Purpose Kit, Cat. No. 56603 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits | Class II | Terminated | |
| Z-1946-2021 | Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits | Class II | Terminated | |
| Z-1945-2021 | Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits | Class II | Terminated | |
| Z-1559-2021 | Kit: Blood Culture MAI Kit Part Number: 80076 | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. | Class I | Terminated | |
| Z-1558-2021 | Kit: Blood Culture. MAI Kit Part Number: 80315D | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. | Class I | Terminated | |
| Z-1557-2021 | Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. | Class I | Terminated | |
| Z-1556-2021 | Kit: Midline Insertion DA. MAI Kit Part Number: 77981B | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. | Class I | Terminated | |
| Z-1555-2021 | Kit: Injection REVIEW MAI Kit Part Number: 74736 | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. | Class I | Terminated | |
| Z-1554-2021 | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. | Class I | Terminated | |
| 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 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 | The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0. | Class II | Terminated | |
| Z-1068-2019 | Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12X12 XR (5 each/pack, 40 pack/case) - Model Number 411; 6. Lap 12X12 XR w/ring (5 each/pack, 40 pack/case) - Model Number 412; 7. Lap 8X36 XR (5 each/pack, 40 pack/case) - Model Number 419; 8. Lap 17X26 XR (5 each/pack, 20 pack/case) - Model Number 426; | Potential lack of sterility assurance | Class II | Terminated | |
| Z-0681-2019 | Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination. | Potential compromise of product sterility due to breach of sterile barrier. | Class II | Terminated | |
| Z-2043-2018 | Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these are intended to be used in accordance with hospital protocol. | Product sterility potentially compromised. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain