6 results
·
58ms
·
Sources: EU EUDAMED, US FDA
MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code HWE·March 2, 2016
THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·September 5, 2023
THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·August 8, 2023
THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·May 30, 2024
THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·January 28, 2019
BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling ***smith&nephew ***#420400***SKIN-PREP Protective Wipes Effective protection between tape and skin Reduces risk of tape stripping Helps tape, film and appliance adhesion Reduces friction Pediatrician tested***1 wipe***For external use only. Do not use with electrocautery procedures. Sting will be experienced if contacts cut or open wound. INGREDIENTS: Isopropyl Alcohol, Butyl Ester of PVM/MA Copolymer, Acetyl Tributyl Citrate. ------------------- Brand: SKIN-PREP Protective Wipes Bulk Case:***smith&nephew***SKIN-PREP Wipes BULK*** REF 420471 QTY 1000 Wipes ***. ------------------- Brand: SKIN-PREP CE Protective Wipes - Pouch Label: ***smith&nephew*** #59420425***SKIN-PREP***Box Label: ***smith&nephew***#59420425 SKIN-PREP 50***Carton Label: smith&nephew Wipes For International Export ***Quantity 20 Cartons of 50 REF #59420425***. ------------------ Brand: PERI-PREP CE Protective Wipes - Pouch Label and Box Label: ***Peri-Prep Peristomal Protective Dressing Wipe Product Code 840001 FOR ***SALTS HEALTHCARE***WARNINGS: Use only as directed. For external use only. do not apply to open wounds or mucus membrane. Avoid contact with eyes. Vapor may be harmful - use with adequate ventilation. Do no use with electrocautery procedures. FLAMMABLE: Do not use near heat, sparks or open flame. Keep out of reach of children. Seek medical advice before use on neonates. FIRST AID TREATMENT: If swallowed, give victim milk or water and induce vomiting. Call physician or poison control center immediately. If inhaled, remove to fresh air. If not breathing give artifical respiration, call physician. In case of contact with eyes, flush with water for 15 minutes including under eyelids. INGREDIENTS; Isopropyl Alcohol, Butyl Ester of PVM/MA Copolymer, Acetyl Tributyl Citrate. Brand: PERI-PREP CE - Case Label: ***smith&nephew Wipes Re-order #84001 ***PERI-PREP CE FLAMMABLE*** Quantity 20 Cartons of 50 REF #5132***. --------------- The following brand name products are manufactured using the same formulation . 1) SKIN-PREP Protective Wipes 50/Box Formulation F-06, Product Code 420400. 2) SKIN-PREP Protective Wipes Bulk Case 1000/Case Formulation F-06, Product Code 420471. [1000 individual wipes in a poly bag placed into a shipping carton.] 3) SKIN-PREP CE Protective Wipes 50/Box Formulation F-06, Product Code 59420425. 4) PERI-PREP CE Protective Wipes 50/Box Formulation F-06, Product Code 5132. Product Usage: Alcohol based liquid film-forming skin preparations that, upon application to intact skin, form a protective film to help reduce friction during removal of tapes and films. Skin-Prep can also be used to prepare skin attachment sites for drainage tubes, external catheters, surround ostomy sites and adhesive dressings.
FDA Recall
Terminated
·Smith & Nephew Inc.·Product code NEC·April 4, 2011