Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility in the packaging process.
DMRC Number: DMRC - 39617055
Company name:Becton Dickinson UK Ltd
Product descriptions:
ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators - PL: 05920/0002, SNOMED code: 40818111000001106, GTIN: 20885403491761 10885403491764
ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL applicators - PL: 05920/0002, SNOMED code: 12775311000001103, GTIN: 27613203022099
Details of the affected batches:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| All lots with an expiry date up to and including 02/2028 * | All lots with an expiry date up to and including 02/2028 | ChloraPrep 1mL Applicator: 60 applicators | 11/09/2023 |
| All lots with an expiry date up to and including 01/2028 * | All lots with an expiry date up to and including 01/2028 | ChloraPrep Frepp™ 1.5 ml Applicators: 20 applicators | 09/01/2024 |
* 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 and ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL 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 02/2028. Batches with an expiry date after 02/2028 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 are being recalled as a precautionary measure.
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/alert: Class 2 Medicines Recall: Becton Dickinson UK Ltd, ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators, EL(26)A/26