InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.

FDA device recall Z-2122-2014 · posted 2014-07-28 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit is damaged, brake functions can be affec

Action taken

On 06/30/1014 the firm sent "Urgent Medical Device Notification" letters to their customers.

Root cause

Device Design

Status

Terminated

Product code

FNL

Quantity affected

11,632 units

Distribution

Worldwide Distribution -USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV,

Date initiated

2014-06-04

Date posted

2014-07-28

Date terminated

2016-03-14

Location

Portage, MI