FDA (Devices) recall action 67710

Teleflex Medical recalled 15 products on 2014-04-02

The FDA (Devices) publishes a recall like this one as 15 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 15 pages.

Products: 15
Announced: 2014-04-02
Critical: 0
Units: 832,815

Why these products were recalled

Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–15 of 15

HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Cannula Due to Gas Leakage
Teleflex Medical is recalling 5/10 mm Weck Vista Universal Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgeries.
Product
5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Cannula Due to Gas Leakage
Teleflex Medical is recalling 55,521 units of Weck Vista Universal Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgeries.
Product
5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Vista Optical Bladeless Laparoscopic Access Port Recalled for Gas Leakage
Teleflex Medical is recalling Vista Optical Bladeless Laparoscopic Access Ports because gas leakage can delay or prevent the completion of laparoscopic surgeries.
Product
5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Recalls Weck Vista Optical Bladeless Laparoscopic Access Ports
Teleflex Medical is recalling 55,521 Weck Vista Optical Bladeless Laparoscopic Access Ports due to reported gas leakage that may delay surgical procedures.
Product
5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports
Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to reported gas leakage that may delay laparoscopic surgeries.
Product
5/10 Weck¿ Vista" Universal Balloon Open Access Port Short Length (53mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports
Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to reported gas leakage that may delay laparoscopic surgeries.
Product
5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage
Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports because they may leak insufflation gas, potentially delaying or complicating laparoscopic surgeries.
Product
Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Port
Teleflex Medical is recalling 55,521 units of the Weck Vista Universal Balloon Open Access Port due to reported gas leakage that may delay laparoscopic surgeries.
Product
5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls 10mm Weck Vista Cannula Due to Gas Leakage
Teleflex Medical is recalling 55,521 units of 10mm Weck Vista Cannula-only devices due to reported leakage of insufflation gas, which may delay laparoscopic surgeries.
Product
10mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage
Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports because complaints were received regarding leakage of insufflation gas, which can delay surgical procedures.
Product
Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports
Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports due to reported gas leakage that may delay surgical procedures.
Product
Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports
Teleflex Medical is recalling 55,521 Weck Vista Universal Balloon Open Access Ports due to gas leakage that may delay laparoscopic surgeries.
Product
5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls 12mm Weck Vista Cannula Due to Gas Leakage
Teleflex Medical is recalling 12mm Weck Vista Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgical procedures.
Product
12mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Cone Open Access Devices
Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices due to reported gas leakage that may delay laparoscopic surgeries.
Product
5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states
HighFDA (Devices)··2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports
Teleflex Medical is recalling 55,521 Weck Vista Universal Balloon Open Access Ports due to gas leakage that may delay laparoscopic surgeries.
Product
5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Distribution
0 states