Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall Z-1434-2016 · Posted 2016-04-14
Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2016-01-07
Date Terminated2017-05-03
Product Quantity25
Reason for Recall
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Firm Action
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
Root Cause
Packaging
Distribution Pattern
Distributed only in Puerto Rico.
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.