🍔 Food 💊 Drugs 🏥 Medical Devices
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment. Class I

Reason: Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.

H & H Associates 20130827 Terminated
Distributed: Nationwide distribution.
View Details
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue. Class II

Reason: Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.

PhotoMedex, Inc. 20130104 Terminated
Distributed: Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.
View Details
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns. Class II

Reason: No antibacterial bandages were packed in boxes labeled as antibacterial.

ASO, LLC 20130821 Terminated
Distributed: Distributed in the states of ID, WI, IN, and NE.
View Details
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. Class II

Reason: Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.

Cordis Corporation 20130812 Terminated
Distributed: Worldwide Distribution - USA Nationwide in the states of AZ, CA, FL, ID, LA, MA, MD, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TX, VA, WI, and WV and the countries of: Austria, Belgium, Czech Republic, France, Germany, Greece,Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Arab, and United Kingdom
View Details
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. Class II

Reason: On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I

King Systems Corp. 20131212 Terminated
Distributed: USA Nationwide Distribution in the state of NY
View Details
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart. Class II

Reason: MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades.

Maquet Cardiovascular, LLC 20130920 Terminated
Distributed: USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.
View Details
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. Class II

Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.

CareFusion 303, Inc. 20130830 Terminated
Distributed: Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI
View Details
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. Class II

Reason: One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.

Medtronic Xomed, Inc. 20130823 Terminated
Distributed: Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
View Details
The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. Class II

Reason: The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged.

Stryker Medical Division of Stryker Corporation 20130819 Terminated
Distributed: Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.
View Details
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants. Class II

Reason: This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.

Synthes USA HQ, Inc. 20130111 Terminated
Distributed: Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.
View Details
Page 3,732 of 4,030 | Showing 10 recalls
Data provided by openFDA