Plastic Surgery And Accessories Kit

FDA product code FTN · Class I (low risk) · 21 CFR 878.3925 · General, Plastic Surgery

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.

0510(k) clearances
0PMA approvals
62recalls

Recalls

RecallProductFirmInitiated
Z-3023-2026 Class IIMedline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375MKits contain a potentially contaminated component which were recalled by the manufacturer Medline Industries, LP07/10/2026Open, Classified
Z-3053-2026 Class IIMedline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375CThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… Medline Industries, LP06/12/2026Open, Classified
Z-2495-2026 Class IIMEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2423-2026 Class IIMedline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST…Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2025-2026 Class IIMedline medical procedure kits, containing Medline Neuro Sponges (102 in total)During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… Medline Industries, LP03/19/2026Open, Classified
Z-2584-2026 Class IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… Medline Industries, LP02/27/2026Open, Classified
Z-1882-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. Medline Industries, LP02/27/2026Open, Classified
Z-1723-2026 Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… Medline Industries, LP02/27/2026Open, Classified
Z-1841-2026 Class IIMedline Kits: 1) BREAST PACK, Model Number: DYNJ66777DThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… Medline Industries, LP02/25/2026Open, Classified
Z-2099-2026 Class IISee RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1397-2026 Class IIMedline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1192-2026 Class IIMedline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… Medline Industries, LP12/12/2025Open, Classified
Z-1054-2026 Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… Medline Industries, LP11/26/2025Open, Classified
Z-0447-2026 Class IConvenience Kit, BREAST HERNIA DYNJ909125GFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… Medline Industries, LP10/10/2025Open, Classified
Z-0519-2026 Class IIMEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2)…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… Medline Industries, LP09/30/2025Open, Classified
Z-1600-2025 Class IIMedline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… MEDLINE INDUSTRIES, LP - Northfield03/03/2025Open, Classified
Z-1367-2025 Class IIProxima Drape labeled as FACE LIFT. Sterile surgical drape.Potential breach in pouch packaging which could lead to loss of sterility. MEDLINE INDUSTRIES, LP - Northfield02/13/2025Open, Classified
Z-1462-2025 Class IIMedline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield02/11/2025Open, Classified
Z-0786-2025 Class IIMedline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… MEDLINE INDUSTRIES, LP - Northfield11/21/2024Open, Classified
Z-0722-2025 Class IISEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… MEDLINE INDUSTRIES, LP - Northfield11/06/2024Open, Classified
Z-0633-2025 Class IIMEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… MEDLINE INDUSTRIES, LP - Northfield10/09/2024Open, Classified
Z-0165-2025 Class IIMedline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… MEDLINE INDUSTRIES, LP - Northfield09/04/2024Open, Classified
Z-3113-2024 Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… MEDLINE INDUSTRIES, LP - Northfield06/27/2024Open, Classified
Z-3016-2024 Class IIMedline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-2750-2024 Class IIMedline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-2707-2024 Class IIMedline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b)…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. MEDLINE INDUSTRIES, LP - Northfield03/22/2024Open, Classified
Z-0824-2024 Class IICustom procedural convenience kits and trays, general & plastic surgery, labeled as: a)…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… American Contract Systems, Inc.11/29/2023Open, Classified
Z-1109-2024 Class IMedline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… MEDLINE INDUSTRIES, LP - Northfield11/15/2023Open, Classified
Z-0173-2024 Class IIBreast Plastics Pack, REF BBPL20DDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… American Contract Systems, Inc.09/01/2023Open, Classified
Z-2177-2023 Class IIMedline 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 - Northfield05/18/2023Open, Classified
Z-2317-2023 Class IICustom 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 - Northfield05/15/2023Open, Classified
Z-1116-2023 Class IISurgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… MEDLINE INDUSTRIES, LP - Northfield12/07/2022Open, Classified
Z-1077-2023 Class IISterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… MEDLINE INDUSTRIES, LP - Northfield11/17/2022Open, Classified
Z-0555-2023 Class IISTRADIS HEALTHCARE, Breast, Item No.693-276,Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0538-2023 Class IISTRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0536-2023 Class IISTRADIS HEALTHCARE, Lipo, Item No.681-254,Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0528-2023 Class IIHENRY SCHEIN, RHINO PACK, Item No.570-3070Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0509-2023 Class IIHENRY SCHEIN, BREAST PACK, Item No.570-2397Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0502-2023 Class IIHENRY SCHEIN, Breast Augmentation tray, Item No.570-0611Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-1697-2022 Class IIBreast Abdominoplasty PackProduct was exposed to multiple sterilization cycles without validation for multiple exposures. American Contract Systems, Inc.06/16/2022Open, Classified
Z-2265-2020 Class IIRegard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD. ROi CPS LLC04/20/2020Terminated
Z-2169-2020 Class IISterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. American Contract Systems04/13/2020Terminated
Z-2101-2011 Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… Argon Medical Devices, Inc03/14/2011Terminated
Z-2100-2011 Argon Medical Devices, Arterial Line Kit 20ga x 3", Part Number 498421B, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… Argon Medical Devices, Inc03/14/2011Terminated
Z-2099-2011 Argon Medical Devices Arterial Line Kit, 18ga x 6", Part Number 498412B, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… Argon Medical Devices, Inc03/14/2011Terminated
Z-2098-2011 Argon Medical Devices, Arterial Line Kit, Part Number 498410B, 20gax6", Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… Argon Medical Devices, Inc03/14/2011Terminated
Z-2097-2011 Argon Medical Devices, Catheter Introducer Kit 5F, Part Number 496190A, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… Argon Medical Devices, Inc03/14/2011Terminated
Z-2096-2011 Argon Medical Devices, Arterial Line Kit, 18ga x 6", Part Number 498443, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… Argon Medical Devices, Inc03/14/2011Terminated
Z-2095-2011 Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit, 20GX3in, Part…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… Argon Medical Devices, Inc03/14/2011Terminated
Z-2094-2011 Argon Medical Devices Arterial Line Kit, 20ga x 1.75", Part Number 498418, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… Argon Medical Devices, Inc03/14/2011Terminated