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Terminated

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

FDA Recall Z-2122-2014 · Posted 2014-07-28

Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeFNL
Date Initiated2014-06-04
Date Terminated2016-03-14
Product Quantity11,632 units

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

Firm Action

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

Root Cause

Device Design

Distribution Pattern

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, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV, and the countries of Argentina, Brazil, Canada, Chile, China, EMEA, Greece, Italy, Japan, Korea, Latin America, Mexico, Poland, Singapore, South Africa, Taiwan, and UK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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