Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

FDA device recall Z-1157-2024 · posted 2024-09-30 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).

Action taken

Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to its consignees on 01/04/2024 via USPS First Class. The notice explained the problem with the device, risk involved, and requested the consignee quarantine then destroy the affected product. Upon receipt of the completed destruction form, firm will issue credit, if applicable. Consignee was directed to notify all parties of this action to whom the product was distributed. For questions, contact 866-359-1704

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KYZ

Quantity affected

4831 units

Distribution

US, Nationwide

Date initiated

2024-01-04

Date posted

2024-09-30

Location

Northfield, IL