Smiths Medical Asd Inc 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
Brand
Smiths Medical Asd Inc
Lot Codes / Batch Numbers
Lot Number: 4398428 4404690
Products Sold
Lot Number: 4398428 4404690
Smiths Medical Asd Inc is recalling 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR due to There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized aff. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE RECALL notification letter dated 11/10/23 was sent to customers. Required Actions for Users: 1. Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Inform potential users of the product in your organization of this notification and complete and return the attached response form to smithsmedical7166@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product and/or it has already been used. 3. If you have distributed the product further, immediately notify your accounts that receive the product identified in the Affected Items / Table 1 sections of this notification and ask them to contact Sedgwick at 1-855-215-5142 (MF, 8am-5pm ET) to obtain a response form. 4. If the product has not already been used, please return affected lots to Smiths Medical and Smiths Medical will offer replacement units. Global Complaint Management globalcomplaints@icumed.com 1-(866)-216-8806 Customer Service 1-(800)-258-5361
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026