Wound Dressing Kit
FDA product code MCY · Class II (moderate risk) · 21 CFR 880.5075 · General Hospital
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
24510(k) clearances
0PMA approvals
100recalls
Manufacturers
- Medical Device Inspection Co., Inc. 2
- Convatec, A Division of E.R. Squibb & Sons 2
- Catalina Biomedical Corp. 2
- Customed, Inc 1
- Johnson & Johnson Medical, Inc. 1
- Grand Medical Products 1
- Suncoast Medical Products, Inc. 1
- Busse Hospital Disposables, Inc. 1
- ETHICON, Inc. 1
- Medsurg Industries, Inc. 1
- Surgipro Central, Inc. 1
- Kit Pak, Inc. 1
- Gesco Intl., Inc. 1
- Orion Life Systems, Inc. 1
- Medi-Flex Hospital Products, Inc. 1
- Great West Medical Equipment, Inc. 1
- Jobst Institute, Inc. 1
- Megadyne Medical Products, Inc. 1
- Dermatological Research Laboratories, Inc. 1
- Continental Medical Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970721 | Dyna-Flex Multi-Layer Compression SystemMCY · Traditional | Johnson & Johnson Medical, Inc. | 03/21/1997SN |
| K963719 | Central Line Dressing Change Tray, Tpn/Cvp Dressing Change TrayMCY · Traditional | Grand Medical Products | 11/27/1996SE |
| K960585 | Wound Care Compression System (WCCS)MCY · Traditional | Suncoast Medical Products, Inc. | 04/26/1996SE |
| K952334 | Dressing Change TrayMCY · Traditional | Busse Hospital Disposables, Inc. | 07/14/1995SE |
| K951022 | Circulon System Step 1MCY · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/12/1995SESK |
| K951021 | Circulon System Step 2MCY · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/12/1995SESK |
| K951476 | E-Pack Procedure KitsMCY · Traditional | ETHICON, Inc. | 05/23/1995SESK |
| K931932 | Dressing Change Tray-ModifiedMCY · Traditional | Medsurg Industries, Inc. | 08/27/1993SEKD |
| K924690 | Various Non-Sterile Custom Trays/KitsMCY · Traditional | Surgipro Central, Inc. | 07/16/1993SEKD |
| K923905 | Wound Dressing KitMCY · Traditional | Kit Pak, Inc. | 07/02/1993SEKD |
| K926063 | Per-Q-Cath Dressing Change TrayMCY · Traditional | Gesco Intl., Inc. | 06/07/1993SEKD |
| K925021 | TPN Tray (Sterile)MCY · Traditional | Customed, Inc. | 06/07/1993SEKD |
| K921347 | Cepti-Seal Dressing Change Kit for Venous CatheterMCY · Traditional | Medi-Flex Hospital Products, Inc. | 01/08/1993SEKD |
| K913480 | Wound Care Tray aMCY · Traditional | Catalina Biomedical Corp. | 10/18/1991SE |
| K912116 | Pressure Sore Management KitMCY · Traditional | Medical Device Inspection Co., Inc. | 10/18/1991SE |
| K912684 | Home Medical Kit - for Little HurtsMCY · Traditional | Great West Medical Equipment, Inc. | 10/15/1991SE |
| K913479 | Wound Care Tray BMCY · Traditional | Catalina Biomedical Corp. | 10/08/1991SE |
| K912232 | UlcercareMCY · Traditional | Jobst Institute, Inc. | 08/14/1991SE |
| K912117 | Laceration TrayMCY · Traditional | Medical Device Inspection Co., Inc. | 08/09/1991SE |
| K910363 | Mega Dressing Change KitMCY · Traditional | Megadyne Medical Products, Inc. | 03/28/1991SE |
| K910011 | Post Surgical Kit/Post Biopsy KitMCY · Traditional | Dermatological Research Laboratories, Inc. | 03/27/1991SE |
| K905123 | G-Tube Dressing Change TrayMCY · Traditional | Continental Medical Laboratories, Inc. | 03/27/1991SE |
| K905572 | Edlich Wound Management TrayMCY · Traditional | Sorex Medical | 03/12/1991SEKD |
| K902811 | Routine Dressing TrayMCY · Traditional | Orion Life Systems, Inc. | 09/25/1990SEKD |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3126-2026 | Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | Medline Industries, LP | 08/11/2026Open, Classified |
| Z-3072-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3057-2026 Class II | Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2)…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-2498-2026 Class II | MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2029-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-2595-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-2103-2026 Class II | Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1402-2026 Class II | Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1331-2026 Class II | Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU…Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD… | Medline Industries, LP | 12/24/2025Open, Classified |
| Z-1711-2025 Class II | Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION…It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… | MEDLINE INDUSTRIES, LP - Northfield | 03/19/2025Open, Classified |
| Z-1445-2025 Class II | Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328BMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 02/11/2025Open, Classified |
| Z-0636-2025 Class II | MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141BMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-3023-2024 Class II | Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2753-2024 Class II | Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588AMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-0593-2024 Class I | Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREEFirm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist… | Busse Hospital Disposables, Inc. | 11/30/2023Open, Classified |
| Z-1135-2024 Class I | Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670AMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-1120-2024 Class I | Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-0311-2024 Class II | PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561This recall is being issued due to items within the kit have expired prior to the overall kit expiration… | MEDLINE INDUSTRIES, LP - Northfield | 11/01/2023Open, Classified |
| Z-2184-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | MEDLINE INDUSTRIES, LP - Northfield | 05/18/2023Open, Classified |
| Z-2324-2023 Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | MEDLINE INDUSTRIES, LP - Northfield | 05/15/2023Open, Classified |
| Z-1120-2023 Class II | Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | MEDLINE INDUSTRIES, LP - Northfield | 12/07/2022Open, Classified |
| Z-1081-2023 Class II | Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-1166-2022 Class II | CVC Dressing Change Kit Catalog Number: 2491R1Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1429-2016 Class II | Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1424-2016 Class II | Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1406-2016 Class II | Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1405-2016 Class II | Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-2593-2015 Class II | DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2557-2015 Class II | WOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2556-2015 Class II | WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-0247-2015 Class I | Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-0241-2015 Class I | Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-0240-2015 Class I | Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-1267-2012 | Wound Management Tray Aten cion med. EN El Hogar, catalog# 900-1903The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | Customed, Inc | 12/08/2011Terminated |
| Z-1266-2012 | Wound Management Ryder, catalog# 900-1605The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | Customed, Inc | 12/08/2011Terminated |
| Z-1265-2012 | Wound Management Tray, catalog# 900-1456The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | Customed, Inc | 12/08/2011Terminated |
| Z-1264-2012 | Wound Management Tray Asoc. Agencia Salud, catalog# 900-1154The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | Customed, Inc | 12/08/2011Terminated |
| Z-1263-2012 | Wound Management Tray, catalog# 900-540The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | Customed, Inc | 12/08/2011Terminated |
| Z-3172-2011 | Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare…Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set… | Medela Inc | 07/27/2011Terminated |
| Z-2377-2011 | Material HT2480, V.A.D. TRAY, CENTURION V.A.D. TRAY, REORDER HT2480, STERILE, CENTURION…This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9%… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2376-2011 | Material HT2440A, VAD ACCESS TRAY, CENTURION VAD ACCESS TRAY, REORDER HT2440A, STERILE…This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9%… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2375-2011 | Material HT2430A, V.A.D.TRAY, CENTURION V.A.D. TRAY, REORDER HT2430A, STERILE, LATEX…This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9%… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2374-2011 | Material HT1995A, V.A.D.TRAY, CENTURION V.A.D. TRAY, REORDER HT1995A, STERILE, CENTURION…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2373-2011 | Material HT2415, VAD ACCESS KIT, CENTURION VAD ACCESS KIT, REORDER HT2415, STERILE…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2356-2011 | Material DT9750, VAD ACCESS TRAY, CENTURION VAD ACCESS TRAY, REORDER DT9750, STERILE…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2354-2011 | Material DT9345E, DRESSING CHANGE TRAY, CENTURION, STRATEGIC HEALTHCARE SOLUTIONS LLC.…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2353-2011 | Material DT9195, PORT ACCESS TRAY, CENTURION PORT ACCESS TRAY, REORDER DT9195, STERILE…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2352-2011 | Material DT9155, PORT ACCESS TRAY W/SORBAVIEW&CHLORAPREP, CENTURION PORT ACCESS TRAY…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2350-2011 | Material DT8415, PORT ACCESS TRAY W/SORBAVIEW SHIELD, CENTURION PORT ACCESS TRAY WITH…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | Centurion Medical Products Corporation | 03/31/2011Terminated |
| Z-2349-2011 | Material DT7890, PORT ACCESS TRAY, CENTURION HEALTHCARE PRODUCTS PORT ACCESS TRAY…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | Centurion Medical Products Corporation | 03/31/2011Terminated |