American Contract Systems, Inc. - Custom procedural convenience kits and trays - Class 2 Recall
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROBOTIC PACK, kit number BPAR65A; g) HIP PINNING PACK, kit number EMHP84; h) HIP PINNING PK, STRL F G, kit number FHHI17V; i) TOTAL HIP PACK, kit number GNTH06L; j) TOTAL KNEE PACK, kit number GNTK07L; k) EXTREMITY PACK, kit number GUEX48I; l) MAJOR ORTHO PACK, kit number GUMO40J; m) TOTAL KNEE ACCESS PACK, kit number HITK58D; n) SHOULDER ARTHROSCOPY...
Source: Medical Device Recalls - January 27, 2024 Category: Medical Devices Source Type: alerts
American Contract Systems, Inc. - Custom procedural convenience kits and trays - Class 2 Recall
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit number BBGP31C; f) FRACTURE TABLE PACK, kit number FDFT75N; g) Arthroscopy Pack, kit number HCAR04K; h) BARIATRIC PACK, kit number HGBA92F; i) LAPAROTOMY PACK, kit number HNLP12J; j) MIDLINE CHANGE KIT, kit number HSMD20E; k) Minor General, kit number JSMI10I; l) ENDO VASCULAR PACK, kit number L...
Source: Medical Device Recalls - January 27, 2024 Category: Medical Devices Source Type: alerts
Stryker Corporation - Portal Entry Kit - Class 2 Recall
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2023 Category: Medical Devices Source Type: alerts
Cardinal Health 200, LLC - Presource - Class 2 Recall
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5) Presource PBDS Cat. POMHLEE11, Kit, Extremity, SE, Sterile; (6) Presource PBDS Cat. POMVTHANLE, Kit, Anterior Hip, Sterile; (7) Presource PBDS Cat. POVMPAB11, Kit, PAO Pack, Barnes Jewish, Sterile; (8) Presource PBDS Cat. PO08LXG21, Kit, Extremity, Grant, Sterile; (9) Presource PBDS Cat. PO11HRFH6, Kit, Anterior Hip, Sterile; (10) Presource PBDS C...
Source: Medical Device Recalls - October 11, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A; e. CRANIOTOMY CDS, Model Number: CDS981753L; f. CRANIOTOMY CDS-1, Model Number: CDS982889I; g. CRANIOTOMY PACK, Model Number: DYNJ61749A; h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722; i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E; j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168; k. FREE F...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number DYNJ44322I; e) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348D; f) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348F; g) IR ARM PACK, Model Number DYNJ50712C; h) HYBRID PACK, Model Number DYNJ56907D; i) TUNNEL PACK, Model Number DYNJ58127B; j) CRANIOTOMY PACK, Model Number DYNJ61749A; k) CARPAL TUNNEL KIT, Model Number DYNJ63149A; l) ANGIOGRA...
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
DeRoyal Industries Inc - Class 2 Recall
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, REF '89-7540; n) EPIDURAL TRAY/CUSTOM, REF '89-8061; o) BRE...
Source: Medical Device Recalls - July 4, 2023 Category: Medical Devices Source Type: alerts
DeRoyal Industries Inc - Class 2 Recall
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK,...
Source: Medical Device Recalls - June 8, 2023 Category: Medical Devices Source Type: alerts
DePuy Mitek, Inc., a Johnson & Johnson Co. - Bioknotless Anchor (Arthroscopic) - Class 2 Recall
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2023 Category: Medical Devices Source Type: alerts
DePuy Mitek, Inc., a Johnson & Johnson Co. - Bioknotless Anchor (Arthroscopic) - Class 2 Recall
DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2023 Category: Medical Devices Source Type: alerts
DePuy Mitek, Inc., a Johnson & Johnson Co. - Bioknotless Anchor (Arthroscopic) - Class 2 Recall
DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2023 Category: Medical Devices Source Type: alerts
DePuy Mitek, Inc., a Johnson & Johnson Co. - Bioknotless Anchor (Arthroscopic) - Class 2 Recall
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2023 Category: Medical Devices Source Type: alerts
DePuy Mitek, Inc., a Johnson & Johnson Co. - Bioknotless Anchor (Arthroscopic) - Class 2 Recall
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Procedure packs - Class 2 Recall
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2023 Category: Medical Devices Source Type: alerts
