Hydrophilic catheters recalled over an incorrect expiration date on labeling
Hangzhou Bever Medical Devices is recalling 149,310 BD Ready-to-Use Hydrophilic Catheters, 14 Fr, over a labeling error giving an incorrect expiration date.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the minor labeling criterion: the record cites an incorrect printed expiration date with no stated consequence or reported harm.
Plain-English summary
The BD Ready-to-Use Hydrophilic Catheter, 14 Fr (4.7 mm), straight tip, coated, female, REF RTU14F, is being recalled by Hangzhou Bever Medical Devices Co., Ltd.
The reason given in the enforcement record is a labeling error: an incorrect expiration date.
The record lists 149,310 units under UDI (01)06948796204063, lot T21823. The distribution field reads 'US Nationwide distribution in the state of GA', which states both a nationwide scope and a single state; both are reported here as printed. The FDA has classified the action as Class II.
The record cites a printed date error and states no consequence or reported injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
- Manufacturer
- HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
- Category
- Medical Device — Catheter
- Hazard
- labeling-error
- expiration-date
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)06948796204063/Lot # T21823
Distribution
Distributed nationwide across the United States.
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