TELEFLEX LLC recalls Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube…
Potential for pilot balloon non-inflation or cuff non-deflation.
Read the official notice →- Date
- 2023-02-01
- Country
- United States
- Brand
- Teleflex
- Product
- Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Teleflex recalls
- 2023-07-05
US
TELEFLEX LLC recalls Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- 2023-06-07
US
TELEFLEX LLC recalls Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or…
Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step…
- 2023-05-24
US
TELEFLEX LLC recalls Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral…
The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.
- 2023-01-04
US
TELEFLEX LLC recalls Pilling Wecksorb Cylindrical Sponges
Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
- 2022-11-23
US
- 2022-10-26
US
TELEFLEX LLC recalls Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
Incidents of device splitting or detaching during use
Other drugs & medical recalls in the United States
- 2023-02-01
US
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
The kit contained an expired component.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of NY, IN, FL, NJ, IL.Official notice →US
CooperVision, Inc. recalls MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
FDA · DeviceCooperVision, Inc.Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and…Official notice →US
Baxter Healthcare Corporation recalls Baxter Electrocardiograph, ELI 380 -DCS21
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
US
Abbott Molecular, Inc. recalls Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing,…
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration…
US
Meridian Bioscience Inc recalls Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
FDA · DeviceMeridian Bioscience IncUS Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN,…Official notice →US
Johnson & Johnson Surgical Vision, Inc. recalls FUSION Dual Pump Packs, REF: OPO73
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France,…Official notice →