Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators due to a potential breach of sterility in the packaging process.
DMRC Number: DMRC - 40102707
Company name:Beckton Dickson UK Ltd
Product description: ChloraPrep 1mL Applicator - PL: 05920/0002, SNOMED code: 40818111000001106, GTIN: 20885403491761
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| All lots with an expiry date up to and including 05/2029* | All lots with an expiry date up to and including 05/2029* | ChloraPrep 1mL Applicator: 60 applicators | 25/06/2025 |
*For a full list of impacted batches, see Annex 1 of the full recall
Background information:
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators due to a potential breach of sterility in the packaging process. The recall applies to all batches with an expiry date up to and including 05/2029. Batches with an expiry date after 05/2029 are not impacted.
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 Annex 1 of the full recall are being recalled as a precautionary measure.
This recall is specific to the lots in included in Annex 1.
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 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/alert: Class 2 Medicines Recall: Beckton Dickson UK Ltd, ChloraPrep 1mL applicator, EL(26)A/34