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

Certain lots containing undersized dilator.

FDAAug 5, 2022Nationwide• Datascope Corporation

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

The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.

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FDAAug 3, 2022Nationwide• Wright Medical Technology, Inc.

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

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

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

CorVocet Biopsy System (Merit) – Needle Ejection (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)

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

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

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

BD MaxGuard 15 Drop Set (CareFusion) – Incorrect Expiration (2022)

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

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

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

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

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

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

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

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

PrednisoLONE Oral Solution (Akorn) – Incomplete Seals (2022)