🔍 RecallPedia

Clinical Innovations

8 recalls •
🍎 Food 🏥 Medical Devices
• Categories: Beverages, Diagnostic Equipment, Other Medical Devices, Infusion Pumps, Surgical Instruments

Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. -VPSU15032250, 1mL vial, bagged qty 250

🍎 Food Class I - Dangerous

Firm received complaints of leaking, black liquid, and black particulates in the product vials.

Jul 19, 2022 Beverages Nationwide View Details →

Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Each box contains 288 cups. Product is aseptically packaged in 15 mL cups with foil lid. Each cup contains 15 mL of USP purified water, 24% sugar, citric acid (buffer). Cup is latex-free, DEHP-free, BPA-free. UPC 00814247020673. Store at room temperature. Product is only used in the hospital setting including the NICU and administered directly to tongue or buccal surface.

🍎 Food Class I - Dangerous

Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.

Jul 19, 2022 Beverages Nationwide View Details →

Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. VPSU15031250, 2mL vial, box qty 250 UPC VPSU15033250, 1mL vial, box 250 UPC VPSU15033250B, 1mL vial, individually wrapped, box qty 250 UPC 00814247020314

🍎 Food Class I - Dangerous

Firm received complaints of leaking, black liquid, and black particulates in the product vials.

Jul 19, 2022 Beverages Nationwide View Details →

Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025

🏥 Medical Devices Class I - Dangerous

Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.

Aug 13, 2020 Diagnostic Equipment View Details →

Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.

🏥 Medical Devices Class I - Dangerous

An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.

May 30, 2019 Other Medical Devices View Details →