Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C

FDA device recall Z-1578-2013 · posted 2013-06-21 · Terminated

Recall details

Recalling firm

Prism Medical Services USA

Reason for recall

The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.

Action taken

The firm, Prism Medical, sent a letter dated January 27, 2013 to is customers.The letter described the product, problem and actions to be taken. The customers were instructed to perform an immediate safety check checking that both the pin and the plug have been inserted into the carry bar as outlined in the attached User Instruction guide. Prism offered to replace the recalled product with a different product with greater functionality. If you have any questions, contact VP-Global Product Development at 416-726-3107.

Root cause

Use error

Status

Terminated

Product code

FNG

Quantity affected

1131 carry bars/New England

Distribution

Worldwide distribution: US (nationwide) and country of: Canada.

Date initiated

2013-01-27

Date posted

2013-06-21

Date terminated

2018-07-18

Location

Maryland Heights, MO