KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
FDA Recall Z-1221-2015 · Posted 2015-02-27
Advertisement
Recalling FirmHalyard Health
Recall StatusTerminated
Product CodeBSY
Date Initiated2015-01-16
Date Terminated2015-07-07
Product Quantity5 cases (20 tubes per case)
Reason for Recall
Defect: A hole or crack was found which may cause air to leak.
Firm Action
Consignees were notified by letter via FedEx on 01/16/2015.
Root Cause
Packaging process control
Distribution Pattern
CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement