Cook Inc. recalls Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal…
Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time…
Read the official notice →- Date
- 2021-11-24
- Country
- United States
- Brand
- Cook
- Product
- Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal…
- Classification
- Class II
- Units
- Domestic distribution nationwide. Foreign distribution worldwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-09-21
USCook 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…
- 2022-06-15
- US
Cook Incorporated recalls Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338…
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
FDA · DeviceCook IncorporatedDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - 2021-12-29
- US
Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced…
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
FDA · DeviceCook Inc.Worldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice → - 2021-12-22
- US
Cook Inc. recalls Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce…
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
FDA · DeviceCook Inc.AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES,…Official notice → - 2021-11-10
- US
Cook Inc. recalls Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath…
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in…
FDA · DeviceCook Inc.Domestic distribution to AR AZ CT FL GA IL LA MA ME MN ND NJ NY OH PA TX WA.…Official notice →
Other drugs & medical recalls in the United States
- 2021-11-24
- US
Beaver Visitec International, Inc. recalls bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent…
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
FDA · DeviceBeaver Visitec International, Inc.Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641…
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances,…
- US
Scrip Inc recalls Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- US
Cordis Corporation recalls SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in…
There is a potential for distal tip dislodgement or separation.
FDA · DeviceCordis CorporationUS Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution…Official notice → - US
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC…
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA · DrugBayer Healthcare Pharmaceuticals Inc.Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a…Official notice → - US
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of…
Chemical Contamination: presence of benzene
FDA · DrugBayer Healthcare Pharmaceuticals Inc.Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a…Official notice →