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LINEAR IAB (Datascope) – Volume Labeling (2022)

The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.

FDAAug 5, 2022Nationwide• Datascope Corporation

Sensation Plus IAB (Datascope) – Dilator Size (2022)

Certain lots containing undersized dilator.

FDAAug 5, 2022Nationwide• Datascope Corporation

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LINEAR IAB (Datascope) – Volume Labeling (2022)

Sensation Plus IAB (Datascope) – Dilator Size (2022)

MEGA Intra-Aortic Balloon (Datascope) – Dilator Size (2022)

Stryker EVOLVE Proline Stem (Wright) – Label Mismatch (2022)

Medline ClearPro Double Swivel Catheter (Medline) – Connector Separation (2022)

Medline ClearPro Trach Catheter (Medline) – Connector Separation (2022)

Collagen Dental Wound Dressing (Collagen Matrix) – Packaging Seal (2022)

Medline ClearPro Trach Catheter (Medline) – Connector Separation (2022)

CorVocet Biopsy System (Merit) – Needle Ejection (2022)

Fabco ORS Dental Rolls (Carwild) – Sterility Concern (2022)

Smallbore Bifuse Extension Set (ICU Medical) – Manufacturing Gap (2022)

BD MaxGuard Drop Set (CareFusion) – Incorrect Expiration (2022)

BD MaxGuard Extension Set (CareFusion) – Incorrect Expiration (2022)

Bifuse Pressure Infusion Set (ICU Medical) – Manufacturing Gap (2022)

BD MaxGuard Flow Controller Set (CareFusion) – Incorrect Expiration (2022)

Extension Set with Clave (ICU Medical) – Manufacturing Gap (2022)

Smallbore Trifuse Extension Set (ICU Medical) – Manufacturing Gap (2022)

UV-C Germicidal Wand (MerchSource) – Radiation Risk (2022)

BD MaxGuard Extension Set (CareFusion) – Incorrect Expiration (2022)

MicroClave Clear Connector (ICU Medical) – Manufacturing Gap (2022)