Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for ...
Reason: Sterility may be compromised
Z-2528-2015September 9, 2015North Haven, CT
Customed, Inc
Class IITerminated
FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2566-2015September 9, 2015Fajardo, PR
Covidien LLC
Class IITerminated
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 Product Usage: Sterile Delivery are indicated for use in flus...
Reason: Sterility may be compromised
Z-2529-2015September 9, 2015North Haven, CT
Halyard Health, Inc
Class IITerminated
KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2493-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 22169) A tracheobronchial suction ca...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2505-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed Suction System for Adults, 12 F, DSE (Product 21603); KimVent* Closed Suction System for Adults, 14 F, DSE (Pr...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2506-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Su...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2520-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use ...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2498-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2494-2015September 9, 2015Alpharetta, GA
Covidien LLC
Class IITerminated
Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushi...
Reason: Sterility may be compromised
Z-2527-2015September 9, 2015North Haven, CT
Halyard Health, Inc
Class IITerminated
NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheob...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2500-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); KimVent* Closed Suction System for Adults, 12 F, T-Piece, 12 in Trach (Product Code 21513511) A tra...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2497-2015September 9, 2015Alpharetta, GA
Covidien LLC
Class IITerminated
MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing...
Reason: Sterility may be compromised
Z-2536-2015September 9, 2015North Haven, CT
Halyard Health, Inc
Class IITerminated
NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) A tracheobronchial suction catheter is a device that is attached to a port of t...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2510-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece MDI Adapter, 14F (Product Code 2V220158) A tracheobronchial suction catheter is a device that is attached to a port of the airwa...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2501-2015September 9, 2015Alpharetta, GA
Covidien LLC
Class IITerminated
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushi...
Reason: Sterility may be compromised
Z-2537-2015September 9, 2015North Haven, CT
Halyard Health, Inc
Class IITerminated
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for us...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2515-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to asp...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2509-2015September 9, 2015Alpharetta, GA
Abbott Electrophysiology
Class IIITerminated
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology proced...
Reason: The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for th...
Z-2478-2015September 9, 2015Menlo Park, CA
Covidien LLC
Class IITerminated
Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 Product Usage: Sterile Delivery are indicated for use in flushi...
Reason: Sterility may be compromised
Z-2532-2015September 9, 2015North Haven, CT
Halyard Health, Inc
Class IITerminated
KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2523-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) A tracheobronchial suction catheter is a device that is attached to a port of the airway ci...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2502-2015September 9, 2015Alpharetta, GA
Halyard Health, Inc
Class IITerminated
KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201358); KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece (Produce Code 2201258) A trache...
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" positi...
Z-2499-2015September 9, 2015Alpharetta, GA
Baxter Healthcare Corp.
Class IITerminated
MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applicat...
Reason: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid fun...
Z-2473-2015September 2, 2015Deerfield, IL
Baxter Healthcare Corp.
Class IITerminated
MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications ...
Reason: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid fun...