Becton Dickinson & Recalls

Hazard: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Hazard: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Hazard: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6.

Hazard: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Hazard: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Hazard: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Hazard: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Hazard: Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.

Hazard: BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered.

Hazard: BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.

Hazard: BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries.

Hazard: The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a possible mis-identification of an organism.

Hazard: BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.

Hazard: A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.

Hazard: BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.

Hazard: BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.

Hazard: BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot Epidural Tray, Cat (Ref) 406069.

Hazard: A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL Ampul, NDC # 0409-4712-01. Some BD" Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being recalled by Hospira. As a result, BD is initiating a recall for the affected BD Spinal Trays.

Hazard: BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.

Hazard: BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.

Hazard: Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of the safety feature, which retracts the needle.

Hazard: BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.

Hazard: BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.

Hazard: The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.

Hazard: Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.

Hazard: The sterility of the product cannot be assured. This may result in increased risk of infection.

Hazard: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.

Hazard: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.

Hazard: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.

Hazard: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.