Forest Devices, Inc.

Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.

FDA Enforcement

Class II ·Terminated·Hospira, Inc.·September 19, 2012

Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.

FDA Enforcement

Class II ·Terminated·Hospira Inc.·August 1, 2012

Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural

FDA Enforcement

Class I ·Terminated·Hospira Inc.·October 31, 2012

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural

FDA Enforcement

Class I ·Terminated·Hospira Inc.·October 31, 2012

SMART PORT CT

FDA Adverse Event

Injury ·ANGIODYNAMICS, INC.·Product code LJT·April 8, 2026

BARD® FLIP-FLO¿ CATHETER VALVE

FDA Adverse Event

Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code KNX·July 24, 2018

Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.

FDA Enforcement

Class II ·Terminated·Hospira Inc.·December 19, 2012

Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list #20679 and 20792, module list number 20677. The Plum A+ Infusion System with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature.

FDA Enforcement

Class II ·Terminated·Hospira Inc.·December 19, 2012

BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

FDA Adverse Event

Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·May 16, 2022

BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

FDA Adverse Event

Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·May 11, 2020

Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680 Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

FDA Enforcement

Class II ·Terminated·Hospira Inc.·December 19, 2012

SL FOLEY SWIVEL SILICONE TRICOT 25BX

FDA Adverse Event

Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EYJ·May 14, 2018

ALIGN® S SUPRAPUBIC URETHRAL SUPPORT SYSTEM

FDA Adverse Event

Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTN·May 24, 2018

BARD® URINARY DRAINAGE BAG

FDA Adverse Event

Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code KNX·August 8, 2018

BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

FDA Adverse Event

Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code KNX·July 25, 2018

BARDEX® I.C. TIEMANN MODEL COUDE TIP FOLEY CATHETER

FDA Adverse Event

Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code MJC·December 23, 2019

AVAULTA PLUS¿ BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR, STERILE

FDA Adverse Event

Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTP·May 3, 2018

Latex-free, Primary I.V. Set, vented, 78 inch with injection site, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 1881-48.

FDA Recall

Terminated ·Hospira Inc.·Product code FPA·November 24, 2009

Latex-free, Primary I.V. Set, vented, 73 inch with flashback bulb, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 8962-48.

FDA Recall

Terminated ·Hospira Inc.·Product code FPA·November 24, 2009

Hospira Transpac IV Monitoring Kit, 60 inch disposable transducer monitoring kit with second stopcock by transducer, continuous flush device and drip chamber; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.

FDA Recall

Terminated ·Hospira Inc.·Product code FPA·January 9, 2006