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Cover, Barrier, Protective

FDA product code MMP · Class 2 · General, Plastic Surgery

316
Registered devices
20
Adverse events
30
Recalls
15
510(k) clearances

Devices with this code

System Cover Kit — PROTEK MEDICAL PRODUCTS, INC.Patterson® — PATTERSON DENTAL SUPPLY, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Henry Schein Chair Cover — HENRY SCHEIN, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Burkhart Cover Film Blue 4X6 (1200) — BURKHART DENTAL SUPPLY CO., THEDeRoyal — DEROYAL INDUSTRIES, INC.Patterson® — PATTERSON DENTAL SUPPLY, INC.Pinnacle Chair Sleeve — METREX RESEARCH, LLCDeRoyal — DEROYAL INDUSTRIES, INC.Medline — MEDLINE INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.MIZUHO OSI — MAYTEX CORPORATIONPinnacle Cover-All — METREX RESEARCH, LLCDeRoyal — DEROYAL INDUSTRIES, INC.Medline — MEDLINE INDUSTRIES, INC.Isoloader Surgical Drape — PROTEK MEDICAL PRODUCTS, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Curaplex — BOUND TREE MEDICAL, LLCEquipment Cover Bag Type — ARGON MEDICAL DEVICES, INC.Medline — MEDLINE INDUSTRIES, INC.Pinnacle X-Ray Sensor Sheaths — METREX RESEARCH, LLCMedline — MEDLINE INDUSTRIES, INC.Pinnacle X-Ray Sensor Sheaths — METREX RESEARCH, LLC

Recent recalls

DateFirmReason
2023-05-18MEDLINE INDUSTRIES, LP - NorthfieldProbe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
2023-05-15MEDLINE INDUSTRIES, LP - NorthfieldPotential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
2020-01-07Stryker CorporationSterile drapes packaged in an unsealed pouch.
2020-01-07Stryker CorporationSterile drapes packaged in an unsealed pouch.
2017-06-27NOVADAQ TECHNOLOGIES INC.The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
2017-06-27NOVADAQ TECHNOLOGIES INC.The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
2017-06-27NOVADAQ TECHNOLOGIES INC.The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
2017-01-23Covidien LLCSterility compromised due to breach in sterile barrier
2017-01-23Covidien LLCSterility compromised due to breach in sterile barrier
2015-02-11Sybron Dental SpecialtiesCases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.