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U.S. Department of Health and Human Services

Class 2 Device Recall AliMed IQ Cupid Pull Cord Alarm

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 Class 2 Recall
AliMed IQ Cupid Pull Cord Alarm
see related information
Date Posted April 16, 2010
Recall Status1 Terminated on July 25, 2011
Recall Number Z-1407-2010
Recall Event ID 54783
Product Classification Monitor, Bed Patient - Product Code KMI
Product Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An adjustable cord is attached to both the alarm and the patient. When the patient moves beyond the length of the cord the pin is pulled and the alarm activated.
Code Information Product Code KMI, Models #710436
Recalling Firm/
Manufacturer
AliMed Corporation
297 High St
Dedham, Massachusetts 02026
Manufacturer Reason
for Recall
Alimed became aware of issue via internal receiving inspection activities on 1/20/09. Firm states that subsequent to this observation, Customer Dissatisfaction inquiry #100192 was generated on 1/22/10. A single unit was received back by AliMed and 0 n/2/1/20 from a rehabilitation center that indicated that it had received a unit and it did not function upon its initial use. Failure of the alarm
FDA Determined
Cause 2
DESIGN: Device Design
Action Letter sent to customers stating that some units may have been subjected to excessive heat during the manufacturing process causing internal distortion to a key alarm component. The letter also request that the Health Care professional review records and notify all users to whom the product may have been issued and if any product has been issued outside of their facility, to forward this correspondence to them. Firm has enclosed a form for return of the product and issuance of a new product. For questions, please contact the firm using the information provided in the letter.
Quantity in Commerce 30 units
Distribution All product was distributed domestically with the exception of one unit sold in Canada. AliMed sells and distributes this product to medical health professionals and distributors as well as directly to end users
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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