184 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FNL·February 23, 2017
Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·April 13, 2009
19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014
19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014
10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014
Zimmer Hemovac Wound Drainage Device with O.P. Adapter, 400 ml COMP EVAC w/O.P. Adapter Component Kit, to be used with OrthoPAT post op suction set, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2696-000-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Sarns Flexible Weighted Sucker in WI CARDIOVASCULAR PUMP & TABLE PACK (custom pack), catalog number 64789-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GCY·February 25, 2011
Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Recall
Terminated
·Cardinal Health 200, LLC·Product code GCY·April 21, 2017
Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
FDA Recall
Terminated
·Vital Concepts, Inc.·Product code GCY·July 11, 2003
Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 1/8" PVC w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2500-700-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-704-10; 400 ml INF. CNTRL. Kit w/ 1/4" Drain Spec., 6.4mm., 19Fr., PVC, 107cm, large, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 31, 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-004-10; 400 ml INF. Cntrl. Kit w/ 1/4" drain, 6.4 mm, 19Fr, PVC, 107 cm, large, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 31, 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-002-10, 400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, medium, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio;
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 31, 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 31, 2008
Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures.
FDA Recall
Terminated
·MicroAire Surgical Instruments, LLC·Product code GCY·April 26, 2012
10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014
Sarns Flexible Weighted Sucker, Sterile, catalog 804113, Terumo Cardiovascular Systems, Ann Arbor, MI. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GCY·February 25, 2011
Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog number 70579-05, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GCY·February 25, 2011
Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GCY·February 25, 2011
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code GCY·May 9, 2016