BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
SKIN STAPLE REMOVER
Centurion Medical Products
Class I - Dangerous
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
ST. CHRISTOPHER'S SECUREMENT SET
Centurion Medical Products
Class I - Dangerous
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
CIRCUMCISION TRAY
Centurion Medical Products
Class I - Dangerous
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
Pressure Injectable Multi- Lumen CVC Kit
Arrow International
Class I - Dangerous
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Class I - Dangerous
Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.
Class I - Dangerous
Label does not state that the product is heparin-coated.
Class I - Dangerous
Label does not state that the product is heparin-coated.
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago
Class I - Dangerous
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago
Class I - Dangerous
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Class I - Dangerous
Label does not state that the product is heparin-coated.
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago
Class I - Dangerous
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
3M Company - Health Care Business
Class I - Dangerous
3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.
Class I - Dangerous
Label does not state that the product is heparin-coated.
Class I - Dangerous
Label does not state that the product is heparin-coated.
Class I - Dangerous
Label does not state that the product is heparin-coated.
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago
Class I - Dangerous
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Class I - Dangerous
Label does not state that the product is heparin-coated.
Class I - Dangerous
Label does not state that the product is heparin-coated.