Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1554-2013Class II

BC Hammock Mesh Sling (Small), product number, 537010

Handicare USA, Inc. / initiated 2013-05-23 / Terminated / root cause: manufacturing process

Prism Medical Services USA began a recall of BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a... on . FDA classified it as Class II and gives the reason as "The product does not meet the firm's size standards, the product was produced in the incorrect size". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1554-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Handicare USA, Inc.
Product
BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
The product does not meet the firm's size standards, the product was produced in the incorrect size.
Root cause tag
manufacturing process
FDA root cause
Employee error
Action
Prism Medical contacted their US consignees on May 28, 2013 with an e-mail notification of the recall. The notification explained the Field Safety Notice Letter dated May 22, 2013. The notice identified the affected product, problem and actions to be taken. Customers were instructed to contact Customer Service at Prism Medical to receive a return goods authorization to replace the affected product at no charge. For questions call 905-850-9003 Ext. 249.
Quantity in commerce
5 slings
Distribution
Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.
Product codes and lots
Lot: PHM000053, PHM000648, PHM000732, PHM000733 and PHM000734.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1554-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1552-2013Class IITerminatedVoluntary: Firm initiated
Z-1553-2013Class IITerminatedVoluntary: Firm initiated
Z-1554-2013Class IITerminatedVoluntary: Firm initiated
Z-1555-2013Class IITerminatedVoluntary: Firm initiated