Stryker Sustainability Solutions - Reprocessed HARMONIC Ace 7, 5mm Diameter Shears with Advanced Hemostasis (HARH) - Class 2 Recall
Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE¿+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedur...
Source: Medical Device Recalls - July 19, 2018 Category: Medical Devices Source Type: alerts
Ethicon Endo-Surgery Inc - HARMONIC ACE Shears Adaptive Tissue Technology - Class 2 Recall
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2018 Category: Medical Devices Source Type: alerts
Ethicon Endo-Surgery Inc - The HARMONIC ACE Shears Adaptive Tissue Technology - Class 2 Recall
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2018 Category: Medical Devices Source Type: alerts
Z-Medica, LLC - QuikClot Trauma Pad - Class 2 Recall
QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 9, 2018 Category: Medical Devices Source Type: alerts
Covidien LP - Vistec TM XRay Detectable Sponges - Class 2 Recall
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 9, 2018 Category: Medical Devices Source Type: alerts
Covidien LLC - Covidien Endo Peanut 5mm Auto Suture Blunt Dissector - Class 2 Recall
Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 24, 2017 Category: Medical Devices Source Type: alerts
Z-Medica, LLC - QuikClot TraumaPad - Class 2 Recall
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2017 Category: Medical Devices Source Type: alerts
Eliquis (apixaban)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Bleeding
Reversal of Anticoagulant Effect
A specific antidote for ELIQUIS is not... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Ethicon, Inc. - EVARREST - Class 2 Recall
EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 16, 2016 Category: Medical Equipment Source Type: alerts
Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk
Risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 6, 2016 Category: American Health Source Type: alerts
Covidien LLC - Curity - Class 2 Recall
Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2016 Category: Medical Equipment Source Type: alerts
Tyvaso (treprostinil)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Risk of Bleeding
(Add) Tyvaso inhibits platelet aggregation and increases the risk of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Xarelto (rivaroxaban)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Risk of Bleeding
Addition of selective serotonin reuptake inhibitors, and serotonin... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated : Class I Recall - Sheath Body may become Separated from Sheath Hub
If the separation occurs, patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss/exsanguination, interruption/loss of intra-aortic balloon pump treatment may occur. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - March 11, 2016 Category: American Health Source Type: alerts
