Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA The kit contains oxyg

FDA device recall Z-2704-2011 · posted 2011-06-29 · Terminated

Recall details

Recalling firm

Vital Signs Devices, a GE Healthcare Company

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.

Action taken

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

Status

Terminated

Product code

BYG

Quantity affected

33,002 units

Distribution

IL

Date initiated

2011-04-26

Date posted

2011-06-29

Date terminated

2013-01-14

Location

Totowa, NJ