Z-1527-2024Class II
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as...
Cook Incorporated / initiated 2024-03-01 / Open, Classified / root cause: packaging
Cook Incorporated began a recall of Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER... on . FDA classified it as Class II and gives the reason as "Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1527-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Cook Incorporated
- Product
- Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
- Product code
- GCB Needle, Catheter
- Reason for recall
- Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Root cause tag
- packaging
- FDA root cause
- Under Investigation by firm
- Action
- Cook Medical issued Urgent Medical Device Recall letter on 3/1/24 to Risk Management/Recall Administration. . Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) 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 product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]). 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 devices 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: [email protected]. Action being Taken by Cook Medical Cook Medical is removing potentially affected products from the market. Additionally, a supplier investigation has been opened to determine the appropriate corrective action(s) to prevent reoccurrence of a similar issue.
- Quantity in commerce
- 296 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
- Product codes and lots
- UDI: (01)00827002094901(17) Lot Number: 15787864, 15804398
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1525-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1526-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1527-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1528-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1529-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1530-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1531-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1532-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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