9 results
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38ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
FDA Recall
Open, Classified
·Thomas Scientific·Product code LIO·July 14, 2020
Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0, M0045665ST0, M0045667ST0, M0045670ST0, M0045672ST0, M0045675ST0, M0045676ST0, M0045690ST0, M0045890ST0, M0045748ST0 and M0045749ST0. Manufactured by Thomas Medical Products, Malvern, PA. Product is intended for use to facilitate the intracardiac placement of interventional devices.
FDA Recall
Terminated
·Boston Scientific Corp·Product code DYB·December 24, 2008
Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M00456650, M00456700, M00456710 and M00456760. Manufactured by Thomas Medical Products, Inc. Product is intended for use to facilitate the percutaneous introduction of various types of cardiovascular catheters into either the right or left side of the heart. The sheath may be exchanged and used for left sided placement, after transseptal puncture has first been obtained by another sheath.
FDA Recall
Terminated
·Boston Scientific Corp·Product code DYB·December 24, 2008
ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·December 14, 2011
Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CGX·December 1, 2009
Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R1-1000, and 7-C7539-R1-500. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CGX·December 1, 2009
Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 unit of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The 5 mL fill in 6 mL syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton, NDC #64253-444-25, catalog #MIH-4425
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·March 20, 2008
Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 12 mL syringe
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·March 20, 2008
Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe
FDA Recall
Terminated
·Medefil Incorporated·Product code NZW·March 20, 2008