Single Use Instrument Tray
FDA product code OJV · Class I (low risk) · 21 CFR 878.4800 · 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
38recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1145-2018 Class II | Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal…1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis… | Merit Medical Systems, Inc. | 09/20/2017Terminated |
| Z-1144-2018 Class II | Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal…2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis… | Merit Medical Systems, Inc. | 09/20/2017Terminated |
| Z-0635-2017 Class II | Procedure Kit. Catalog Numbers K12-04830B and K12-YP030AMerit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due… | Merit Medical Systems, Inc. | 09/23/2016Terminated |
| Z-0634-2017 Class II | Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232GMerit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due… | Merit Medical Systems, Inc. | 09/23/2016Terminated |
| Z-0633-2017 Class II | Waste Management Kit. Catalog Number K10-04381APMerit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due… | Merit Medical Systems, Inc. | 09/23/2016Terminated |
| Z-0632-2017 Class II | Manifold Kit. Catalog Number K09-11867APMerit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due… | Merit Medical Systems, Inc. | 09/23/2016Terminated |
| Z-0631-2017 Class II | Fluid Management Set. Catalog Number K08-MP5159AMerit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due… | Merit Medical Systems, Inc. | 09/23/2016Terminated |
| Z-0246-2012 | Angiotech***TLok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0245-2012 | Angiotech*** Custom Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0244-2012 | Angiotech*** Custom Bone Marrow Tray for Louis Weiss Memorial Hospital***1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0243-2012 | Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0242-2012 | Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 4 -Towel; 1 -19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0241-2012 | Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 1 - #11 Mini Scalpel…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0240-2012 | Angiotech***Custom General Biopsy Tray for St. Johns Mercy Hospital*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0239-2012 | Angiotech***Custom General Biopsy Tray for Palos Community Hospital*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0238-2012 | Angiotech***Custom General Biopsy Tray for OMA North of Oklahoma City*** 1 - 60cc…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0237-2012 | Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0236-2012 | Angiotech***Custom General Biopsy Tray for Emory University Hospital*** 1 - CSR Wrap 48"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0235-2012 | Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0234-2012 | Angiotech***Custom Bone Marrow Tray for Hackensack University Medical Center*** 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0233-2012 | Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 -Fenestrated Drape; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0232-2012 | Angiotech***Custom Bone Marrow Tray for Tyler Hematology Oncology*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0231-2012 | Angiotech***Custom Bone Marrow Tray for Kaiser Foundation Hospitals*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0230-2012 | Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0229-2012 | Angiotech***Custom Bone Marrow Tray for University of CA, Davis*** 1 - 10cc Syringe L/L…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0228-2012 | Angiotech***Custom Bone Marrow Tray for University of Chicago*** 2- 20ga x 1 " Safety…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0227-2012 | Angiotech***Custom Bone Marrow Tray for New York Hospital/Cornell Medical Center*** 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0226-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0225-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0224-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0223-2012 | Angiotech***T-Lok Bone Marrow Tray w/ Safety Needles***1 - #11 Retractable Scalpel; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0222-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0221-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0220-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0219-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0218-2012 | Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0217-2012 | Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |
| Z-0216-2012 | Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | Medical Device Technologies, Inc. | 12/22/2010Terminated |