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Showing 5821–5840 of 11714 results

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Sodium Bicarbonate Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of Particulate Matter; identified as glass

Class IHigh

FDADec 21, 2023Nationwide• Pfizer Inc.

Freskaro Magnesium Citrate Laxative (Pharma Nobis) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

Medline Blood Culture Kit (Medline) – kit quality issue (2023)

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.

Low

FDADec 21, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

FLEXSelect Latex Elastics (G & H Wire) – mislabeling risk (2023)

Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy

High

FDADec 21, 2023Nationwide• G & H Wire Company

CVS Health Magnesium Citrate Laxative (Pharma Nobis) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

Bard Nasogastric Tube (C.R. Bard) – suction tube performance (2023)

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

High

FDADec 20, 2023Nationwide• C.R. Bard Inc

Bard Suction Connector (C.R. Bard) – suction tube performance (2023)

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

High

FDADec 20, 2023Nationwide• C.R. Bard Inc

Bard PreVent Filter (C.R. Bard) – suction tube performance (2023)

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

High

FDADec 20, 2023Nationwide• C.R. Bard Inc

Bard Lopez Valve (C.R. Bard) – suction tube performance (2023)

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

High

FDADec 20, 2023Nationwide• C.R. Bard Inc

Zyno Medical Z800 Pump (Zyno Medical) – alarm volume issue (2023)

When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death

High

FDADec 20, 2023Nationwide• Zyno Medical LLC

Barco MDSC Flowcell (Barco) – cable manufacturing problem (2023)

Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.

Moderate

FDADec 20, 2023Nationwide• Barco N.V. President Kennedypark 35 Kortrijk Belgium

Global Medium (CooperSurgical) – embryo development risk (2023)

The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.

High

FDADec 20, 2023Nationwide• CooperSurgical, Inc.

Bard Nasogastric Tube (C.R. Bard) – suction tube performance (2023)

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

High

FDADec 20, 2023Nationwide• C.R. Bard Inc

Medline Bleach Wipes (Medline) – shelf life concern (2023)

There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.

Low

FDADec 20, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Accessory Set Syringes (OriGen) – Qualification Concern (2023)

Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.

Moderate

FDADec 19, 2023CA, DE, FL +8 more• OriGen Biomedical, Inc.

Medfusion 3500 Pump (Smiths Medical) – software alarm issue (2023)

Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.

High

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Medfusion Barrel Clamp (Smiths Medical) – pump component risk (2023)

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

Moderate

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Medfusion 4000 Pump (Smiths Medical) – software alarm issue (2023)

Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.

High

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

Moderate

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Medfusion Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

Moderate

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

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