🍔 Food 💊 Drugs 🏥 Medical Devices
BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood. Class II

Reason: The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.

Becton Dickinson & Company 20130710 Terminated
Distributed: Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.
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Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology. Class II

Reason: Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

Lumenis, Inc. 20130819 Terminated
Distributed: Distributed in the states of NJ, PA, and IL.
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HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. Class II

Reason: During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.

HemoCue AB 20130715 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIAN FEDERATION, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, VIET NAM & YEMEN. .
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"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. Class II

Reason: The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.

Edwards Lifesciences, LLC 20130731 Terminated
Distributed: Nationwide Distribution including MO and MI.
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StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients. Class II

Reason: A component Superior endplate manufactured from a different polymer than specified

Spine Wave, Inc. 20130514 Terminated
Distributed: Distributed in the states of FL and OR.
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Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Class II

Reason: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

Covidien LLC 20130816 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the country of Bermuda
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Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Class II

Reason: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

Covidien LLC 20130816 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the country of Bermuda
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Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Class II

Reason: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

Covidien LLC 20130816 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the country of Bermuda
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Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Class II

Reason: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

Covidien LLC 20130816 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the country of Bermuda
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Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Class II

Reason: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

Covidien LLC 20130816 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the country of Bermuda
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