Tray, Irrigation, Sterile
Gastroenterology, Urology · 21 CFR 876.5980
Recent MDR events
9 adverse event reports on file
- IRRIGATION SET, Y-TYPEApr 25, 2014InjuryMedline Industries, Inc.1417592-2014-00041
- SYRINGE, BARD, IRRIGATIONJun 20, 2012MalfunctionBard2633289
- NV LARGE BORE Y-IRRIGATION SETJan 25, 2005MalfunctionHospira De Costa Rica Ltd.9615050-2005-00014
- HYDRO SURG IRRIGATORFeb 19, 2004MalfunctionDavol, Inc, A Div Of C.r. Bard Inc.512101
- IRRIGATION TRAYFeb 15, 2001MalfunctionRusch Inc.2429473-2001-00019
- BARD IRRIGATION SETMay 21, 1999MalfunctionC.r. Bard224738
- STERILE IRRIGATION TRAYSep 19, 1994MalfunctionMedline Industries, Inc.MW1003426
- SUPER VITRECTOMYJan 28, 1993Alcon Laboratories4801
- GASTRANIMALSJul 29, 1992InjuryApplied Medical Technology, Inc.3488
Event type breakdown
Recalls
3 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-3013-2024 · View FDA record ↗ - Customed, IncTerminatedDec 16, 2014
Irrigation Tray With Bulb Syringe, Catalog number 900-020.
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Z-0238-2015 · View FDA record ↗ - Medline Industries IncOpen, ClassifiedUnknown
Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
Samples in the identified lot were found to have incomplete or open packaging seals.
Z-2358-2019 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
15 clearances for this product code
- Clinical Resources, Inc.Jan 12, 1995
K944882 · IRRIGATION TRAY
- American Healthcare Corp.Jun 17, 1993
K923941 · IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
- American Healthcare Corp.Jun 17, 1993
K923939 · IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER
- American Healthcare Corp.Jun 17, 1993
K923938 · IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER
- American Healthcare Corp.Jun 17, 1993
K923940 · IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE
- Kit Pak, Inc.Apr 23, 1990
K900148 · KIT PAK IRRIGATION TRAY
- Orion Life Systems, Inc.Apr 19, 1990
K900737 · PISTON IRRIGATION TRAY
- Orion Life Systems, Inc.Apr 17, 1990
K900736 · BULB IRRIGATION TRAY