Z-0026-2007
ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
Extended Care Air Therapy Systems Inc / initiated 2006-04-05 / Terminated
Extended Care Air Therapy Systems Inc began a recall of ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed on . The reason FDA records is "Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0026-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Extended Care Air Therapy Systems Inc
- Product
- ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
- Product code
- FNL Bed, Ac-Powered Adjustable Hospital
- Reason for recall
- Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall
- FDA root cause
- Other
- Action
- The firm sent a Product Advisory Letter to their distributor/customers on 4/5/2006. The letter instructs the distributors as to the correct way to handle the beds during movement, loading, and unloading onto delivery trucks. The letter also urges the distributors to inspect the bed frame units in inventory at their locations for the presence of any bending, or damage to the four frame bolts. The letter states that the company will replace the bolts as soon as possible when ever necessary.
- Quantity in commerce
- 102 beds
- Distribution
- The recalled medical beds were distributed to six (6) wholesale/distributor customers located in the following states: KS, TN, MI, PA, and LA.
- Product codes and lots
- Serial Numbers: E9084 - E9094 & E10001 - E10099. The serial # is found at the bottom of the stick on label. The label is affixed to the foot of the bed frame on the right hand side.
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