Recall Z-2426-2023

Reason for recall

Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.

FDA-determined cause: Nonconforming Material/Component

Action taken

BD issued an URGENT: Medical Device Product Recall notice to its consignees on 13 July 2023 via FedEx 2-day and email. The notice explained the problem with the device, the risk to the patient, and requested the following actions: Medical facilities: - Discontinue the use of the affected device and destroy it - Share the notice with all users within your facility network - If the product was purchased through a distributor, contact the distributor directly for further instructions. Distributors were directed to Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this recall notification on BD s behalf. Questions: Phone: 1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted, M-F 8am - 5pm CT Email: productcomplaints@bd.com