Cardiovascular Surgical Instruments Tray
FDA product code OFA · Class I (low risk) · 21 CFR 870.4500 · Cardiovascular
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
21recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1455-2016 Class II | Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-2649-2015 Class II | OPEN HEART PACK 1/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2602-2015 Class II | OPEN HEART TRAY CUSTOMED 1/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2581-2015 Class II | OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2572-2015 Class II | OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-0945-2015 Class II | Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer… | Centurion Medical Products Corporation | 10/23/2014Terminated |
| Z-0942-2015 Class II | Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer… | Centurion Medical Products Corporation | 10/23/2014Terminated |
| Z-0356-2015 Class I | Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient care…Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the… | Customed, Inc | 10/08/2014Terminated |
| Z-0307-2015 Class I | Open Heart Tray, Catalog number 900-170. Used by medical staff to perform patient care…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-0298-2015 Class I | Cirugia Cardiovascular Case Cart, Catalog number 900-1500. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-0291-2015 Class I | Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-0288-2015 Class I | Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform patient care…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-0281-2015 Class I | Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient care…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |
| Z-2532-2014 Class I | Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2531-2014 Class I | Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1)…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2498-2014 Class I | Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2482-2014 Class I | Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2433-2014 Class I | OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1)…Customed has determined that there is the possibility that packaging integrity may be compromised on differ… | Customed, Inc | 05/20/2014Terminated |
| Z-2389-2014 Class I | OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5)…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2311-2014 Class I | OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-0001-2014 Class II | Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during…MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling… | Maquet Cardiovascular, LLC | 09/20/2013Terminated |