Class 2 Medicines Recall: BD ChloraPrep Clear - 1mL Applicator, Becton Dickinson UK Ltd, EL(25)A/22
Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This defect could increase the risk of the applicator device being contaminated with pathogens, which could lead to increased infection rates for the patients.
DMRC Number: DMRC-35522050
Company name: Becton Dickinson UK Ltd
Product description: BD ChloraPrep Clear - 1mL Applicator: PL05920/0002, SNOMED code: 40818011000001105, GTIN: 20885403491761
Details of the affected batches:
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 4099824 | 30-Apr-27 | 60 applicators | 18/07/2024 |
| 4099828 | 30-Apr-27 | 60 applicators | 24/07/2024 |
| 4108755 | 30-Apr-27 | 60 applicators | 15/08/2024 |
| 4108759 | 30-Apr-27 | 60 applicators | 11/09/2024 |
| 4116445 | 30-Apr-27 | 60 applicators | 30/07/2024 |
| 4120316 | 30-Apr-27 | 60 applicators | 05/08/2024 |
| 4120319 | 30-Apr-27 | 60 applicators | 12/08/2024 |
| 4121513 | 30-Apr-27 | 60 applicators | 14/08/2024 |
| 4121515 | 30-Apr-27 | 60 applicators | 14/08/2024 |
| 4255105 | 30-Sep-27 | 60 applicators | 24/02/2025 |
| 4255107 | 30-Sep-27 | 60 applicators | 06/01/2025 |
| 4255108 | 30-Sep-27 | 60 applicators | 17/02/2025 |
| 4257774 | 30-Sep-27 | 60 applicators | 23/01/2025 |
| 4257778 | 30-Sep-27 | 60 applicators | 23/01/2025 |
| 4257776 | 30-Sep-27 | 60 applicators | 13/01/2025 |
| 4257777 | 30-Sep-27 | 60 applicators | 20/01/2025 |
| 4259473 | 30-Sep-27 | 60 applicators | 13/01/2025 |
| 4275220 | 31-Oct-27 | 60 applicators | 19/02/2025 |
| 4276062 | 31-Oct-27 | 60 applicators | 03/03/2025 |
| 4276059 | 31-Oct-27 | 60 applicators | 19/02/2025 |
| 4276075 | 31-Oct-27 | 60 applicators | 19/02/2025 |
| 4276079 | 31-Oct-27 | 60 applicators | 10/03/2025 |
Brief description of problem:
Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This defect could increase the risk of the applicator device being contaminated with pathogens, which could lead to increased infection rates for the patients.
The number of impacted units in each batch is unknown, therefore the batches included in the table above are being recalled as a precautionary measure. This recall does not impact other batches of BD ChloraPrep Clear - 1mL Applicator that remain available for clinical use.
Advice to Healthcare Professionals:
Stop supplying the affected batches. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice to Patients:
No further action is required by patients as this product is used by healthcare professionals only and they will have taken the action to remove this product from use.
The recall is a precautionary measure to mitigate any additional risk of infection.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Company contacts for further information:
For all medical information enquiries and information on this product, please email safetyinformation@bd.com, or telephone 08000437546.
For stock control enquiries please email info@insightbio.com, or telephone 01707351330.
To access the full recall: Class 2 Medicines Recall: BD ChloraPrep Clear - 1mL Applicator, Becton Dickinson UK Ltd, EL(25)A/22