ICU Medical, Inc. recalls Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX…
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic…
Read the official notice →- Date
- 2022-09-14
- Country
- United States
- Brand
- ICU Medical
- Product
- Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution including in the states 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-11-27
USICU 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.
- 2023-05-24
- US
ICU Medical Inc recalls Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
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…
- 2022-11-23
- US
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC…
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
- 2022-09-21
- US
ICU Medical, Inc. recalls 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
FDA · DeviceICU Medical, Inc.U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN,…Official notice →
Other drugs & medical recalls in the United States
- 2022-09-14
- US
Datascope Corporation recalls MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Certain lots containing undersized dilator.
FDA · DeviceDatascope CorporationAwaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech…Official notice → - US
Saranas, Inc. recalls Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is…
FDA · DeviceSaranas, Inc.US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ,…Official notice → - US
Medline Industries Inc. recalls Medline CHEST TUBE REORDER NO: DYNJ36762A
Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
FDA · DeviceMedline Industries Inc.U.S. Nationwide distribution in the state of AL.Official notice → - US
BALT USA, LLC recalls Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
- US
Abbott Molecular, Inc. recalls Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic…
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
FDA · DeviceAbbott Molecular, Inc.Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO,…Official notice → - US
OrthoPediatrics Corp recalls Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of…
FDA · DeviceOrthoPediatrics CorpUS Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign:…Official notice →