Arrow International (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP recall — FDA Z-1331-2018
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Complete FDA and NHTSA recall records dated in April 2018.
These records include useful source details for the selected month.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic…
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated…
All American Seasonings is recalling Lost Cajun Gumbo Base because an ingredient was contaminated with Salmonella.
Original Smoked Oysters, packaged in vacuum pouches, are recalled because the product is not intended to be packaged in a vacuum pouch. This product is cold smoked and low salt and will not…
A packaging revision and lack of revision to the corresponding packaging batch record caused the labeling for the firm's Signature Care brand Calcium Chews dietary supplement to declare a…
Case labeling (shrink-wrap labeling) for Diet Pepsi 6 packs (6-16oz bottles) may indicate that the product is "Now Aspartame Free" when the product actually contains aspartame. The…
A sample was collected by the Florida Department of Agriculture and Consumer Services and the analysis revealed that the product contains undeclared sulfites.
The firm recalled cheese after a sample tested positive for Listeria monocytogenes by the State of New York.
Amaranth Flour is recalled due to potential for contamination with Salmonella.
Bruschetta Dip and Bruschetta Mix are recalled because they contain undeclared Milk & Soy.
Smoked Scallops, packaged and frozen in vacuum pouches, are recalled because product did not meet minimum Water Phase Salt (WPS) percentage of 3.5%.
Failed impurities/degradation specifications: Failure to water content and impurity
The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit…
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of…
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (PK) color…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.