ICU Medical, Inc. recalls ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The…
Due to finished goods incorrectly packaged and labeled.
Read the official notice →- Date
- 2024-12-18
- Country
- United States
- Brand
- ICU Medical
- Product
- ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution in the state of IL and the country of…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More ICU Medical recalls
- 2025-05-21
USICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA,…Official notice →- 2025-03-19
- US
ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045,…
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
- US
ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest,…
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling…
- 2024-11-27
- US
ICU Medical, Inc. recalls Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List…
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are…
FDA · DeviceICU Medical, Inc.Worldwide distribution: US (nationwide) including Puerto Rico and OUS…Official notice → - 2024-08-21
- US
ICU Medical Inc recalls Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971,…
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the…
FDA · DeviceICU Medical IncWorldwide Distribution: US (nationwide) and OUS (foreign) countries of:…Official notice → - 2023-08-30
- US
ICU Medical Inc recalls Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453,…
Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
Other drugs & medical recalls in the United States
- 2024-12-18
- US
Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
- US
Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
- US
Microline Surgical, Inc. recalls Microscissor Tip (Disposable); Microline Catalog #: 3122.
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
FDA · DeviceMicroline Surgical, Inc.Worldwide - US Nationwide in the state of OK and the country of Japan.Official notice → - US
Folsom Metal Products, Inc. recalls DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1.…
Units were not intended for commercial distribution and inadvertently distributed.
- US
- US
Ascend Laboratories, LLC recalls Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend…
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit