August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENT
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIAL
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLA
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVE
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CARO
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLA
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FI
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASC
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN H
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTR
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PA
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC M
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) S
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model N
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CP
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART L
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANEST
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BAN
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Hazard: Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
August 9, 2023Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Hazard: Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
August 9, 2023Medical DevicesFDA
Materialise N.V. recalls ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgica
Hazard: Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request