Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
FDA Recall Z-0969-2013 · Posted 2013-03-18
Recalling FirmMolded Products Inc
Recall StatusTerminated
Product CodeKOC
Date Initiated2012-06-19
Date Terminated2013-08-14
Product Quantity1200 sets
Reason for Recall
The recalled product leaks at the connection site.
Firm Action
The firm's one customer was notified of the recall by phone call on 5/8/2012. The customer returned the affected product once the replacement product was received.
Root Cause
Process control
Distribution Pattern
Distributed to one customer in Michigan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.