Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA The kit contains oxygen masks and blood pressure cuffs use on pediatric patients
FDA Recall Z-2704-2011 · Posted 2011-06-29
Recalling FirmVital Signs Devices, a GE Healthcare Company
Recall StatusTerminated
Product CodeBYG
Date Initiated2011-04-26
Date Terminated2013-01-14
Product Quantity33,002 units
Reason for Recall
Broselow Pediatric Emergency System Kit may contain oxygen masks that may contain a potentially sticky substance on the inside and/or outside of the mask.
Firm Action
GE issued an URGENT MEDICAL DEVICE CORRECTION letter dated April 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the affected product, isolate all affected product, complete the attached confirmation form and fax back per the instructions and return any unused product.
For any product forwarded to any other healthcare institution, customers were instructed to forward a copy of the URGENT MEDICAL DEVICE CORRECTION letter to those institutions.
For any questions contact Vital Signs Customer Service at 1-800-932-0760.
Root Cause
Other
Distribution Pattern
IL
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.