C. R. Bard, Inc.

Due to stain present on the surface of affected foley catheters.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.

Cather packaging may contain the incorrect French size.

Cather packaging may contain the incorrect French size.

Cather packaging may contain the incorrect French size.

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

Complaints relating to urine output measurement accuracy.

There is a potential to leak from the catheter where it connects to the drain bag

There is a potential to leak from the catheter where it connects to the drain bag

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

There is potential for a white paper-type residue attached to the catheter.

Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic means such as but not limited to alternative systems, such as open IAP measurement options or exchanging the tubing system, which does not require invasive maneuvers.

BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

Foley Catheter with Incorrect Retainer Cap Print

BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.

Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.

Hydrogel peeling from the pads.

The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.

Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.

Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.

Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.

Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.

Activity and quantity of seeds sent in shipments were incorrect.

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.

Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.

Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).

Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

The product contained a latex catheter instead of a silicone catheter.

During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.