Medical Device Recall: Z-0026-2007

FDA Recalls dataset · Firm: Extended Care Air Therapy Systems Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2006-04-05 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0026-2007.

Recall Res Number
Z-0026-2007
Recalling Firm / Manufacturer
Extended Care Air Therapy Systems Inc
FEI Number
3002498894
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2006-04-05
Date Posted
2006-10-14
Date Terminated
2012-09-21
Product Code
FNL
Event Number
36125
Product Quantity
102 beds
Product Description ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
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
Action Details 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.
Distribution Pattern The recalled medical beds were distributed to six (6) wholesale/distributor customers located in the following states: KS, TN, MI, PA, and LA.
Code Information / Serial Numbers 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.

Related Establishments / Registrations

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