Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
All Recalls
95,114 total recalls in our database
HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
LYFO Disk
Microbiologics
🏥 Medical Devices Class I - Dangerous
LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
JAGTOME RX 44-20-260-035 Material Number: M00573040
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Sam Medical Products
🏥 Medical Devices Class I - Dangerous
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
DREAMTOME 44-30MM/260CM Material Number: M00584050
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Microbiologics
🏥 Medical Devices Class I - Dangerous
Distributed product did not undergo proper release testing.
🏥 Medical Devices Class I - Dangerous
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
JAGTOME RX 39-30-260-025 Material Number: M00573100
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
JAGTOME RX 39-20-450-025 Material Number: M00573090
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
LivaNova Deutschland GmbH
🏥 Medical Devices Class I - Dangerous
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
DREAMTOME 49-20MM/260CM Material Number: M00584000
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
🏥 Medical Devices Class I - Dangerous
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.
DREAMTOME 49-30MM/450CM Material Number: M00584030
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
JAGTOME RX 49-20-260-035 Material Number: M00573000
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach