Cook Incorporated recalls Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725),…
There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure…
Read the official notice →- Date
- 2023-05-17
- Country
- United States
- Brand
- Cook
- Product
- Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725),…
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Cook recalls
- 2024-10-16
USCook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to…
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
FDA · DeviceCook IncorporatedInternational distribution to the country of Australia.Official notice →- 2024-07-03
- US
Cook Incorporated recalls Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety…
Product labels state the incorrect expiration dates that extends beyond their true expiration date
- 2024-04-24
- US
Cook Incorporated recalls Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into…
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
FDA · DeviceCook IncorporatedWorldwide distribution - US Nationwide and the countries of AT, AU, BR, CA,…Official notice → - 2022-10-05
- US
Cook Incorporated recalls Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
FDA · DeviceCook IncorporatedDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - 2022-09-21
- US
Cook Incorporated recalls Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter…
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
FDA · DeviceCook IncorporatedNationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU…Official notice → - 2022-07-20
- US
Cook Incorporated recalls Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a…
Other drugs & medical recalls in the United States
- 2023-05-17
- US
Aesculap Implant Systems LLC recalls Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during…
Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the state of OH.Official notice → - US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide Distribution: PR, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA,…Official notice → - US
Cordis US Corp recalls ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical…
- US
The Harvard Drug Group recalls Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo…
Product mixup: one foreign tablet found in product.
- US
Apotex Corp. recalls Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL…
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
- US
Camber Pharmaceuticals Inc. recalls Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,…
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.