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Sources: EU EUDAMED, US FDA
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Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 0 Injection sites, PVC cassette, non-PVC lined tubing, non-PVC drip chamber. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 8, 2005
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Specialty Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 0 injection sites, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Model Number I8C290 (Reorder No. 21-0317-25) for product distributed Internationally. Model Number 8C290 (Reorder No. 21-0304-01) for product distributed within the United States.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016