Sentara Infusion Services Recalls

FDADec 27, 2022Nationwide• Sentara Infusion Services

Cefoxitin 1GM/2GM (Sentara Infusion) – sterility concern (2022)

Lack of sterility assurance

FDADec 27, 2022Nationwide• Sentara Infusion Services

Precision Delivery Set (Quest Medical) – Tubing Detachment Risk (2022)

Delivery Sets may have tubing that could become detached that could result in patient infection.

Moderate

FDA

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Dec 23, 2022

Nationwide

• Quest Medical, Inc.

myNeedle Guide Software (Siemens) – Orientation Label Error (2022)

In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped

FDADec 22, 2022Nationwide• Siemens Medical Solutions USA, Inc

ADVIA Centaur HBeAg Test (Siemens) – Interference Risk (2022)

Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are performed on the same sample

FDADec 22, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Epi-Caine (Pine Pharmaceuticals) – Raw Material Discoloration (2022)

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

FDADec 22, 2022Nationwide• Pine Pharmaceuticals, LLC

Luminos dRF Max Imaging System (Siemens) – Collision Risk (2022)

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

EVIS EXERA III Colonovideoscope (Olympus) – Procedure Misuse (2022)

A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

FDADec 21, 2022Nationwide• Olympus Corporation of the Americas

Luminos Agile Imaging System (Siemens) – Collision Risk (2022)

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

Luminos Agile Max Imaging System (Siemens) – Collision Risk (2022)

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

Uroskop Omnia Max System (Siemens) – Collision Risk (2022)

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

Luminos dRF Imaging System (Siemens) – Collision Risk (2022)

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

FDADec 21, 2022Nationwide• Siemens Medical Solutions USA, Inc

Relay Pro Stent-Graft (Bolton Medical) – Length Discrepancy (2022)

The product may be shorter than packaging indicates

FDADec 20, 2022Nationwide• Bolton Medical Inc.

Rifampin Capsules USP (Amerisource) – Impurity Specifications (2022)

Failed Impurities/Degradations Specifications

FDADec 20, 2022Nationwide• Amerisource Health Services LLC

GE Nuclear Medicine System (GE) – Detector Fall Risk (2022)

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Very High

FDADec 19, 2022Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Artis Zee Imaging System (Siemens) – Backup Mode Risk (2022)

In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

FDADec 16, 2022Nationwide• Siemens Medical Solutions USA, Inc

Mammotome MammoStar (Carbon Medical) – Label Mismatch (2022)

The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.

FDADec 16, 2022Nationwide• Carbon Medical Technologies, Inc.

ARTIS Imaging Systems (Siemens) – Table Connection Failure (2022)

Mechanical connection between the tabletop and table base may be lost.

FDADec 16, 2022Nationwide• Siemens Medical Solutions USA, Inc

Ganciclovir Injection (Hikma) – Label Mix-up (2022)

Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.