Cardiovascular Surgical Instruments Tray
Cardiovascular · 21 CFR 870.4500
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.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
21 recall events for this product code
- Customed, IncTerminatedApr 14, 2016
Catalog Number: 9002618
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1455-2016 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
OPEN HEART TRAY 1/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2572-2015 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
OPEN HEART TRAY 1/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2581-2015 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
OPEN HEART TRAY CUSTOMED 1/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2602-2015 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
OPEN HEART PACK 1/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2649-2015 · View FDA record ↗ - Centurion Medical Products CorporationTerminatedJan 8, 2015
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 report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Z-0942-2015 · View FDA record ↗ - Centurion Medical Products CorporationTerminatedJan 8, 2015
Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Z-0945-2015 · View FDA record ↗ - Customed, IncTerminatedDec 16, 2014
Open Heart Tray, Catalog number 900-1196C
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-0281-2015 · View FDA record ↗ - Customed, IncTerminatedDec 16, 2014
Open Heart Tray, Catalog number 900-1393.
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-0288-2015 · View FDA record ↗ - Customed, IncTerminatedDec 16, 2014
Cirugia Cardiovascular Case Cart, Catalog number 900-1415A.
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-0291-2015 · View FDA record ↗
Registered firms
20 firms currently registered for this product code
Honduras Kitting, S.a.
Villanueva Cortes, HN
Cardinal Health 200, Llc
Waukegan, IL, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Steris Corporation
Saint Louis, MO, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics U.s., Llc
Charlotte, NC, US
Teleflex Medical Llc
Morrisville, NC, US
Cardinal Health
Hazelwood, MO, US
Deroyal Industries, Inc.
POWELL, TN, US
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.
Cuauhtemoc Chihuahua, MX
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Cardinal Health 200, Llc
El Paso, TX, US
Deroyal Industries, Inc.
POWELL, TN, US
Isomedix Operations Inc
El Paso, TX, US
Isomedix Operations Inc
EL PASO, TX, US
On-x Life Technologies Inc.
Austin, TX, US
Sterilization Services Of Virginia
RICHMOND, VA, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.