Recall Z-1407-2010
AliMed Corporation · initiated February 12, 2010
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.
Codes / lots: Product Code KMI, Models #710436
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: Device Design
Action taken
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.
Details
- Recall number
- Z-1407-2010
- Initiated
- February 12, 2010
- Posted by FDA
- April 16, 2010
- Terminated
- July 25, 2011
- Product code
- KMI – Monitor, Bed Patient
- Quantity
- 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
- Recalling firm
- AliMed Corporation, Dedham, MA