31 results
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Sources: EU EUDAMED, US FDA
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Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·March 8, 2016
Liko Universal Sling Bar 450 Quick Release Hook (QRH) Product Number: 3156085
FDA Recall
Terminated
·Liko, Inc.·Product code FRW·June 13, 2007
Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·June 15, 2016
Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp., Minneapolis, MN 55411
FDA Recall
Terminated
·Coloplast Corp·Product code FQH·November 12, 2007
Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
FDA Recall
Terminated
·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007
Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Coloplast Corp., Minneapolis, MN 55411
FDA Recall
Terminated
·Coloplast Corp·Product code FQH·November 12, 2007
Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
FDA Recall
Terminated
·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007
Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers: ASP 165, ASP 170, Coloplast Corp., Minneapolis, MN 55411
FDA Recall
Terminated
·Coloplast Corp·Product code FQH·November 12, 2007
0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FQH·May 8, 2015
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code FQH·October 4, 2010
Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
FDA Recall
Terminated
·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007
Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
FDA Recall
Terminated
·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007
Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet
FDA Recall
Terminated
·EXP Pharmaceutical Services Corp·Product code FQH·February 11, 2015
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code FQH·January 24, 2019
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code FQH·September 5, 2017
The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code FQH·October 4, 2010
Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
FDA Recall
Terminated
·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007
Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210
FDA Recall
Terminated
·Boston Scientific Corporation·Product code EQH·February 7, 2007
Irrisept Wound Debridement and Cleansing System. 12 units per case.
FDA Recall
Terminated
·IrriMAX Corporation·Product code FQH·August 16, 2019
1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FQH·November 9, 2017