FDA (Devices) recall action 77127

Cardinal Health 200, LLC recalled 20 products on 2017-05-31

The FDA (Devices) publishes a recall like this one as 20 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 20 pages.

Products: 20
Announced: 2017-05-31
Critical: 0
Units: —

Why these products were recalled

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

The agency’s own wording, quoted from the enforcement report.

1–20 of 20

HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains
Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaq
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaqu
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaqu
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Wound Drains Due to Sterility Concerns
Cardinal Health is recalling specific lots of Jackson-Pratt PVC Round Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque sect
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains
Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section o
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section o
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opa
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radi
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-op
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a rad
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section o
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The w
Category
Distribution
0 states
HighFDA (Devices)··2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
Category
Distribution
0 states