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
Read the official notice →- Date
- 2024-04-24
- Country
- United States
- Brand
- Cook
- Product
- Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-11-20
USCook Incorporated recalls Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Affected device lots have labels that state the incorrect expiration dates.
- 2024-10-16
- US
Cook 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
- 2023-05-17
- US
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…
- 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 →
Other drugs & medical recalls in the United States
- 2024-04-24
- US
SonarMed Inc recalls AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
FDA · DeviceSonarMed Inc_AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_Official notice → - US
SURGICAL SPECIALTIES recalls POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Complaints have been received with allegations of Incorrect Needle Curvature.
FDA · DeviceSURGICAL SPECIALTIESDomestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.Official notice → - US
Ethicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM)…
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- US
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021,…
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Ireland,…Official notice → - US
SonarMed Inc recalls AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
FDA · DeviceSonarMed IncDomestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX,…Official notice → - US
Draeger Medical, Inc. recalls Dr¿ger Perseus A500 Anesthesia Workstation
Unexpected shutdown while operating on battery power.
FDA · DeviceDraeger Medical, Inc.Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia,…Official notice →