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    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·December 23, 2020

    Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·November 16, 2020

    Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·August 22, 2012

    CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code MQB·August 29, 2013

    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code IZL·August 29, 2013

    Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code KPR·July 25, 2012

    A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code DRC·September 8, 2014

    Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.

    FDA Recall
    Terminated ·CooperSurgical, Inc. D.B.A. Lone Star Medical Products·Product code DRC·September 13, 2013

    Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

    FDA Recall
    Terminated ·Cook Inc.·Product code DRC·February 1, 2019

    HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DRC·January 19, 2021

    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DRC·March 15, 2016

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Recall
    Terminated ·Cook Inc.·Product code DRC·October 8, 2021

    Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DRC·January 19, 2021

    ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW5U, G4RZ7L, G4T33Y & G4T58C. Product Code #: 03B11LPH- Lot #'s: G4RX8G, G4RZ3X & G4T03X. Product Code #: 03B11LT- Lot #'s: G4RH57, G4RH49, G4RJ9H, G4RK2U, G4RK90, G4RL5P, G4RM16, G4RM1F, G4RM7E,G4RN1E, G4RP3L, G4RT0T, G4RT9D, G4RV4M, G4RV4D, G4RW9Z, G4RX5R, G4RY23, G4RY7P, G4RZ6G, G4T093, G4T167, G4T22M, G4T27A, G4T27W, G4TC7V, G4TD1U, G4TE1P, G4TF0N, G4TF3J, G4TH07, G4TG6D, G4TH5L, G4TJ44, G4TK1J, G4TK6E, G4TL3A, G4TL95, G4TM49, G4TM88, G4TN2H, G4TN88, G4TP1R, G4TP4X, G4TP89,G4TR4X, G4TT3K, G4TT97, G4TU8J, G4TV4W, G4TW1C, G4TX0C & G4TX8Z. Product Code #: 03B11LTH-Lot #'s: G4RW20, G4T03Y, G4T26Y, G4T49F, G4T73A, G4TX0R & G4TX9D. Product Code # 03B12LP-Lot #'s: G4RV5F, G4RY26, G4T27X, G4T55H & G4T75Y. Product Code #: 03B12LPH-Lot #'s: G4RW5T, G4RZ3Y, G4T03Z, G4T32C & G4T49G. Product Code #: 03B12LT-Lot #'s: F4PX6F, F4PZ4D, F4PZ22, F4PY9K, F4PY9E, F4PZ6F, F4PZ9Z, F4R01X, F4R039, F4R00M, F4R09W, F4R10Z, F4R15N, F4R18K, F4R18E, F4R234, F4R255, F4R278, F4R256, F4R35D, F4R34N, F4R34L, F4R369, F4R393, F4R40J, F4R44A, F4R458, G4R601, G4R71Y, G4R71Z, G4R80H, G4R77Z, G4R77Y, G4R860, G4R87V, G4R920, G4R915, G4R962, G4R97Z, G4R84L, G4RA7D, G4RA8N, G4RC45, G4RC79, G4RC8D, G4RC98, G4RD2A, G4RC8E, G4RD24, G4RD4V, G4RE84, G4RG18, G4RG3T, G4RG83, G4RF0A, G4RH0C, G4RG31, G4RG32, G4RF8C, G4RJ08, G4RJ92, G4RJ9E, G4RK6L, G4RL02, G4RL1L, G4RL2E,G4RL8P, G4RL8Y, G4RM31, G4RM49, G4RN06, G4RN27, G4RN30, G4RN2K, G4RN5D, G4RN8F, G4RN7Z, G4RP1K, G4RR2N, G4RR3K, G4RT28, G4RT09, G4RT3G, G4RT3J,G4RU8H, G4RV1F, G4RV1G, G4RV89, G4RV8J, G4RW55, G4RW54, G4RX59, G4RZ15, G4RY7W, G4RY8V, G4RY8W, G4RZ29, G4RZ6W, G4RZ6V, G4RZ6H, G4RZ6U, G4T01U, G4T04J, G4T04H, G4T14X, G4T23R, G4T296, G4T34K, G4T36A, G4T34P, G4T41E, G4T44W, G4T46C, G4T45N, G4T50W, G4T529, G4T63Z, G4T66H, G4T64N, G4T66J, G4T750, G4T70Y, G4T711, G4T73J, G4T78T, G4T81R, G4T78U, G4T83Y, G4T93A, G4T87T, G4T95J, G4T90T, G4T89V, G4T94W, G4T941, G4T940, G4T976, G4TA1E, G4TA5W, G4TA7D, G4TA5X, G4TA9H,G4TA96, G4TC3Y, G4TC4Y, G4TC4X, G4TC80, G4TD3W, G4TD3G, G4TF02, G4TD8Z, G4TD9Z, G4TF8Z, G4TG0W, G4TG31, G4TG4H, G4TG6X, G4TH16, G4TH5M, G4TH79, G4TJ2A, G4TJ6U, G4TJ5W, G4TJ8Y, G4TJ9W, G4TK2F, G4TK86, G4TK9H, G4TL5Z, G4TL7R, G4TL9N, G4TM5T, G4TM3H, G4TM87, G4TP14, G4TR1F, G4TP7K, G4TR54, G4TR3A, G4TR7H, G4TR9M, G4TT0G, G4TT20, G4TT43, G4TT7R, G4TU1D, G4TU3J, G4TV22, G4TU89, G4TW0N, G4TV5V, G4TW3V, G4TW5U, G4TX16, G4TX2D, G4TX8R, G4TX7E & G4TY19. Product Code #: 03B12LTH- Lot #'s: G4RW31, G4RW2R, G4RZ48, G4T00F, G4T27C, G4T448, G4T56N, G4T549, G4T59L, G4T65G, G4T709, G4TE35, G4TF2E, G4TG03, G4TG73, G4TH21, G4TM00, G4TT3F, G4TU3P &G4TX0T. Product Code #: 03B12SRT- Lot #'s: G4RW52, G4RZ25, G4T05J, G4T465 & G4T76T. Product Code #: 04B12XT-Lot #'s: G4RU2U, G4RW8N, G4RV59, G4RW97, G4T19T, G4T79U, G4TA2A, G4TA7K, G4TD2C, G4TF0R, G4TJ1L, G4TM3X, G4TN8E, G4TR00, G4TT2W, G4TW4E, G4TW55 & G4TY7G. Product Code #'s: 03CB11LT-Lot #'s: G4RH8R, G4RK9Z, G4RL5R, G4RM8H, G4RN6Z, G4RT08, G4RV2F, G4RY0X, G4RZ5N, G4T12D, G4T20J, G4T31F, G4T444, G4T50E, G4TL5Y, G4TL8F, G4TU70 & G4TX6J. Product Code #: 03CB12LT-Lot Code #'s: F4R421, G4R93M, G4R989, G4RA4E, G4RA7Z, G4RA8M, G4RC4N, G4RD94, G4RG1F, G4RG4X, G4RG91, G4RH7X, G4RJ9A, G4RN3R, G4RR4T, G4RT8H, G4RU3C, G4RU6V, G4RV2U, G4RW9J, G4RY1R, G4RY6L, G4RZ68, G4T092, G4T14D, G4T229, G4T243, G4T26W, G4T31T, G4T32W, G4T37M, G4T37N, G4T410, G4T449, G4T45Z, G4T47R, G4T48G, G4T551, G4T71V, G4T74Z, G4T81K, G4T83U, G4T894, G4T92T, G4T98R, G4TA4Z, G4TA9X, G4TC2L, G4TC6L, G4TD1E, G4TD68, G4TE07, G4TE9W, G4TF2M, G4TG16, G4TG61, G4TG8P, G4TH58, G4TJ2G, G4TJ99, G4TK3H, G4TK1H, G4TL76, G4TM3D, G4TM5W, G4TN2E, G4TN81, G4TP0V, G4TP9D, G4TR4W, G4TR77, G4TU0L, G4TU86, G4TV4F, G4TV9F, G4TW9U & G4TX7P. Product Code #: 02D11LT- Lot Code #'s: G4RR2U, G4RR34, G4RT5N, G4RT47, G4RT53, G4RU05, G4RX11, G4RX7V, G4RZ28, G4RZ4M, G4T06C, G4T09H, G4T171, G4T18U, G4T28K, G4T38Y, G4T46L, G4T51N, G4T55T, G4T590, G4

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code DRC·September 27, 2010

    Angiotech Vascular Access Needle. A) "Modified Potts/Cournand" Needle. STERILE. Product Number: MPCN1802. 510k K974745. Qty Dist. - 425. B) "Seldinger" Needle. STERILE. Product Number: SN1802, SN1902. 510k K974745. Qty Dist. - 5,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Vascular Access Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code DRC·September 1, 2009

    5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code DRC·March 12, 2018