Broselow/Hinkle Pediatric Emergency System Vital Signs Inc. 20 Campus Road Totowa, NJ 07512 USA The system supplies you

FDA device recall Z-0939-2012 · posted 2012-02-02 · Terminated

Recall details

Recalling firm

Vital Signs Devices, a GE Healthcare Company

Reason for recall

Povidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica.

Action taken

GE Healthcare sent a recall letter/return response form dated October 17, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to not use the affected product, isolate and discard all affected product. Fill out the attached Confirmation form and fax back to 800-535-7923 per the instructions to obtain replacement Busse IV Start Kits. Also, consignees were instructed to return the attached response form even if no recalled product was in their inventory. If they forwarded any affected product to any other healthcare institutions, they should forward a copy of the letter to those institutions. For any questions regarding this recall call 1-800-932-0760.

Root cause

Material/Component Contamination

Status

Terminated

Product code

OGL

Quantity affected

6675 kits

Distribution

Nationwide and Foreign

Date initiated

2011-10-17

Date posted

2012-02-02

Date terminated

2013-01-15

Location

Totowa, NJ