CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Recall Z-2672-2015 · Posted 2015-09-03
Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeOHM
Date Initiated2015-07-10
Date Terminated2017-04-12
Product Quantity507
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
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
Root Cause
Packaging
Distribution Pattern
Distributed Only in Puerto Rico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.