Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Prime 5th Wheel Stryker Medical Stretchers Model 1105 Intended to transport patients in a horizontal position.

FDA Recall Z-2865-2011 · Posted 2011-07-22

Recall StatusTerminated
Product CodeFPO
Date Initiated2011-07-19
Date Terminated2013-08-29
Product Quantity80

Reason for Recall

The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa

Firm Action

Stryker Medical sent an "Urgent Medical Device Correction" dated July 19 ,2011 to all affected customers. The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt of the letter was also included. For additional information call (269) 389-6604.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: Nationwide (USA) including the states of NY, MI, LA and CA ,and the countries of Canada, China, Spain, Japan, Korea, United Kingdom, South Africa.

Official Source

View FDA Recall →

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

↑