63 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3, BIOMET SPORTS MEDICINE, 56 EAST BELL DRIVE, P.O. BOX 587, WARSAW, IN 46581 USA, STERILE After the Curvtek device is used to drill a "C" shaped tunnel through the patient's bone, the device is used to pass suture through the tunnel so that soft tissue may be tied down directly onto the bone.
FDA Recall
Terminated
·Biomet, Inc.·Product code GAB·March 10, 2011
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
FDA Recall
Terminated
·Medline Industries Inc·Product code GAB·April 24, 2018
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
FDA Recall
Terminated
·Medline Industries Inc·Product code GAB·April 24, 2018
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
FDA Recall
Terminated
·Medline Industries Inc·Product code GAB·April 24, 2018
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
FDA Recall
Terminated
·Medline Industries Inc·Product code GAB·April 24, 2018
MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
FDA Recall
Terminated
·Medline Industries Inc·Product code GAB·April 24, 2018
Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N. Rockwell St., Chicago, IL 60618
FDA Recall
Terminated
·Hu-Friedy Mfg Co, Inc.·Product code GAB--·April 10, 2003
MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
FDA Recall
Terminated
·Medline Industries Inc·Product code GAB·April 24, 2018
(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow¿ STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow¿ STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow¿ INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow¿ STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 26, 2020
(1) Arrow STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·December 20, 2019
Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE L/Free (2) 3/4 ABS. REINFORCED SHEET (1) PLASTIC SHEET (5) DRAPE SHEET SMS (18) CLOTH HUCK TOWELS Blue (4) CLOTH HUCK TOWELS White (1 0) ABSORBENT TOWELS L/Free (4) GOWN IMP. BREATHABLE LGE. (3) MAYO STAND COVER L/Free (2) IMPERV. STOCKINETTE (1) WRAPPER 54" X 54" (1) TRAY PLATFORM LGE (1) TABLE COVER HD L/Free (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OFA·May 20, 2014
Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services (Oxygen), PSI 2015, Aluminum Cylinders, InterMed Gas Products LLC Industrial Division, 2056 Vista Parkway West Palm Beach, FL 33411.
FDA Recall
Terminated
·Intermed Gas Products Corporation·Product code ECX·March 27, 2009
Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.
FDA Enforcement
Class II
·Terminated·SALTER LABS·July 4, 2012
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
FDA Enforcement
Class II
·Terminated·Salter Labs·July 30, 2014
NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
FDA Enforcement
Class II
·Terminated·Salter Labs·September 23, 2015
Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.
FDA Enforcement
Class II
·Terminated·SALTER LABS·November 27, 2013
T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
FDA Enforcement
Class II
·Terminated·Salter Labs·February 17, 2016
On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Recall
Terminated
·On Site Gas Systems Inc.·Product code CAW·December 19, 2013
Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE L/Free (2) 3/4 ABS. REINFORCED SHEET (1) PLASTIC SHEET (5) DRAPE SHEET SMS (18) CLOTH HUCK TOWELS Blue (4) CLOTH HUCK TOWELS White (1 0) ABSORBENT TOWELS L/Free (4) GOWN IMP. BREATHABLE LGE. (3) MAYO STAND COVER L/Free (2) IMPERV. STOCKINETTE (1) WRAPPER 54" X 54" (1) TRAY PLATFORM LGE (1) TABLE COVER HD L/Free (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.
FDA Enforcement
Class II
·Terminated·Wexford Labs Inc·November 27, 2013