BD recalled 149,310 hydrophilic catheters due to a labeling error regarding expiration dates. The recall affects the 14 Fr (4.7 mm) straight tip model, REF: RTU14F. Healthcare providers and patients must stop using the product immediately.
Labeling error, Incorrect expiration date
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact HANGZHOU BEVER MEDICAL DEVICES CO., LTD. or your healthcare provider for instructions. Notification method: Letter
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The recall involves the BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female, REF: RTU14F. Approximately 149,310 units are affected, distributed nationwide in the U.S., particularly in Georgia. The catheters were sold under the brand Hangzhou Bever Medical Devices Co.
The recall stems from a labeling error that includes incorrect expiration dates. This mislabeling can lead to the use of outdated medical devices, posing high health risks to patients.
As of the report date, no specific injuries or incidents have been reported related to the use of the affected catheters. However, the potential for harm remains significant given the nature of the device.
Patients and healthcare providers should stop using the affected catheters immediately. Contact Hangzhou Bever Medical Devices Co. for further instructions regarding the return or disposal of the product.
For more details, reach Hangzhou Bever Medical Devices Co. or refer to the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1061-2026.
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