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Cover, Barrier, Protective
FDA product code MMP · Class 2 · General, Plastic Surgery
316
Registered devices
19
Adverse events
30
Recalls
15
510(k) clearances
Devices with this code
Set Up Cover — ARGON MEDICAL DEVICES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Equipment Cover Dome Type — ARGON MEDICAL DEVICES, INC.Pinnacle X-Ray Sensor Sheaths — METREX RESEARCH, LLCDeRoyal — DEROYAL INDUSTRIES, INC.CT Control Cover — PROTEK MEDICAL PRODUCTS, INC.Pinnacle Tray Sleeve — METREX RESEARCH, LLCPatterson® — PATTERSON DENTAL SUPPLY, INC.DeRoyal — DEROYAL INDUSTRIES, INC.STRADIS — STRADIS MEDICAL, LLCSTRADIS — STRADIS MEDICAL, LLCSTRADIS — STRADIS MEDICAL, LLCV. Mueller — CAREFUSION 2200, INCMIZUHO OSI — MAYTEX CORPORATIONPATTERSON — PATTERSON DENTAL SUPPLY, INC.Pinnacle No-Slip Chair Sleeve — METREX RESEARCH, LLCCT Control Rail Cover — PROTEK MEDICAL PRODUCTS, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Medline — MEDLINE INDUSTRIES, INC.Medline — MEDLINE INDUSTRIES, INC.PullUp Storage Cover — PROTEK MEDICAL PRODUCTS, INC.COLABEL — MEDLINE INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-18 | MEDLINE INDUSTRIES, LP - Northfield | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2020-01-07 | Stryker Corporation | Sterile drapes packaged in an unsealed pouch. |
| 2020-01-07 | Stryker Corporation | Sterile drapes packaged in an unsealed pouch. |
| 2017-06-27 | NOVADAQ TECHNOLOGIES INC. | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| 2017-06-27 | NOVADAQ TECHNOLOGIES INC. | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| 2017-06-27 | NOVADAQ TECHNOLOGIES INC. | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| 2017-01-23 | Covidien LLC | Sterility compromised due to breach in sterile barrier |
| 2017-01-23 | Covidien LLC | Sterility compromised due to breach in sterile barrier |
| 2015-02-11 | Sybron Dental Specialties | Cases 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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