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U.S. Department of Health and Human Services

Class 1 Device Recall Blue Rhino G2Multi Percutaneous Tracheostomy Introducer

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  Class 1 Device Recall Blue Rhino G2Multi Percutaneous Tracheostomy Introducer see related information
Date Initiated by Firm April 07, 2023
Date Posted May 10, 2023
Recall Status1 Open3, Classified
Recall Number Z-1427-2023
Recall Event ID 92083
510(K)Number K193133  
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
Product Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
Code Information C-PTIS-100-HC-G-EU-FLEX7.5 (G57695): UDI-DI 00827002576957, Lot Number 14842940; C-PTIS-100-HC-G-EU-FLEX8.5 (G57696): UDI-DI 00827002576964, Lot Numbers 14727192, 14332964, 14335896, 14380758, 14380755, 14332978, 14332973, 14335892, 14335893, 14464000, 14332985, 14464008, 14463988, 14503228, 14503224, 14503222, 14503229, 14503227, 14742869, 14742870, 14727207, 14742873; C-PTIS-100-HC-G-NA-FLEX7.5 (G57691): UDI-DI 00827002576919, Lot Numbers 15063922, 15063923, 15103482, 14227740, 14221180, 14204927, 14227743, 14221125, 14221198, 14221190, 14163328, 14250265, 14250269, 14317245, 14317213, 14345634, 14376893, 14633088, 14633089, 14794549, 14794548, 14794547, 14874486, 14874484, 14926500, 14967737, 14926505, 14967739, 14967741, 14221180; C-PTIS-100-HC-G-NA-FLEX8.5 (G57692): UDI-DI 00827002576926, Lot Numbers 14608362, 14750607, 14894816, 14264399, 14299799, 14299802, 14299803, 14345667, 14365693, 14365699, 14365696, 14365694, 14365701, 14345687, 14345587, 14456438, 14456443, 14456431, 14407846, 14750610, 14488394, 14488418, 14608361, 14608363, 14750618, 14608360, 14961742, 14961716, 15089037, 15089038, 15136113
Recalling Firm/
Manufacturer		 Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Department
812-339-2235
Manufacturer Reason
for Recall		 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 connection between the device connector and circuit components, cap, or accessories.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An URGENT: MEDICAL DEVICE RECALL dated 4/7/23 was sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Sets and Trays from the Cook Medical lots in Attachment A. If so, quarantine any affected sets/trays that remain unused. Immediately cease all further distribution and use of the affected sets/trays. 2. Return the complete sets/trays to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected sets/trays on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected sets/trays have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. Action being Taken by Cook Medical Cook Medical is removing potentially affected products from the market and replacing potentially defective tracheostomy tubes with new tracheostomy tubes as they become available from Medtronic. We recognize that this situation is a potential disruption to your normal operations, and we sincerely apologize. Thank you for your immediate assistance in this matter. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. We look forward to your return of the Acknowledgement and Receipt Form.
Quantity in Commerce 3.053 units
Distribution Worldwide distribution - US Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JOH and Original Applicant = Cook Incorporated
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