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Showing 3861–3880 of 68218 results

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DLP Pediatric Arterial Cannulae (Medtronic) – Incorrect Labeling (2024)

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

FDADec 12, 2024Nationwide• Medtronic Perfusion Systems

Tutti-Frutti (Three Rivers) - Undeclared Coloring (2024)

Undeclared Allergen

Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.

Class IIModerate

FDADec 12, 2024CT, DE, MD +6 more• Shata Traders Inc.

HealthFirst Mail-In Monitoring System (HF Acquisition) – Envelope Printing Error (2024)

Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.

Moderate

FDADec 11, 2024AL, AK, AZ +47 more• HF Acquisition Co LLC

AquaFlexFlow UF 500 Plus (Nuwellis) – Weight Mismatch Risk (2024)

Laceration Risk

The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.

FDADec 11, 2024Nationwide• Nuwellis Inc

LVIS Intraluminal Support Device (MicroVention) – Stent Deployment Issue (2024)

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

FDADec 11, 2024Nationwide• MICROVENTION INC.

VidaSlim 90-day (Vidaslim Co.) – toxic yellow oleander (2024)

Due to the presence of Toxic yellow oleander

FDADec 11, 2024Nationwide• Vidaslim Co.

Daily Veggies Enoki Mushroom (New Age International) – listeria risk (2024)

may be contaminated with Listeria monocytogenes

FDADec 11, 2024MD, NY• New Age International, Inc.

Wellsley Farm Greek Yogurt (Hood) - Foreign Objects (2024)

Products may contain foreign objects (plastic).

Class IIModerate

FDADec 11, 2024CT, KY, MD• HP Hood (VERNON)

Chlorpromazine Tablets 25mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Chlorpromazine Tablets 10mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Wellsley Farm Greek Yogurt (HP Hood) – foreign objects (2024)

Products may contain foreign objects (plastic).

Class IIModerate

FDADec 11, 2024CT, KY, MD• HP Hood (VERNON)

Connie's Thin Crust Pizza (Palermo Villa) – plastic contamination (2024)

Foreign material (plastic)

Class IIModerate

FDADec 11, 2024IL, MN, WI• Palermo Villa, Inc

Great Value Chicken Broth (Tree House) - Packaging Failure (2024)

Potential for packaging failures that could compromise the sterility of the product, resulting in spoilage.

Class IIModerate

FDADec 11, 2024AL, AR• TREE HOUSE FOODS INC

Medtronic NanoCross Elite PTA Catheter (Unknown) – Balloon Deflation Issue (2024)

There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

FDADec 10, 2024Nationwide

EMPOWR 3D Knee Tibial Insert (Unknown) – Surgical Kit Mismatch (2024)

Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.

FDADec 10, 2024Nationwide

Neo-Tee T-Piece Resuscitator (Mercury Medical) – Flow Controller Defect (2024)

Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

FDADec 10, 2024Nationwide• Mercury Enterprises, Inc. dba Mercury Medical

Dapsone Gel 7.5% (VIONA) – Crystallization Issue (2024)

Crystallization

Class IIModerate

FDADec 10, 2024Nationwide• VIONA PHARMACEUTICALS INC

Chow Ciao Broccoli Nuggets (Better Brands) – metal contamination (2024)

Contains foreign object (metal)

Class IIModerate

FDADec 10, 2024Nationwide• Better Brands Inc.

Dapsone Gel 7.5% (Viona) – Crystallization (2024)

Crystallization

Class IIModerate

FDADec 10, 2024Nationwide• VIONA PHARMACEUTICALS INC

Yu Yee Five Spice Powder (Summit Import) – high lead levels (2024)

Product tested and found high levels of lead.

Class IIModerate

FDADec 10, 2024AK, CT, FL +12 more• Summit Import Corporation

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