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U.S. Department of Health and Human Services

Class 2 Device Recall BC Hammock Mesh Sling

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 Class 2 Device Recall BC Hammock Mesh Slingsee related information
Date Initiated by FirmMay 23, 2013
Date PostedJune 19, 2013
Recall Status1 Terminated 3 on November 25, 2013
Recall NumberZ-1553-2013
Recall Event ID 65263
Product Classification Lift, patient, non-ac-powered - Product Code FSA
ProductBC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
Code Information Lot: PHM000884, PHM000881, PHM000882, PHM000883 and PHM000885.
Recalling Firm/
Manufacturer		 Prism Medical Services USA
45 Progress Pkwy
Maryland Heights MO 63043-3701
For Additional Information ContactAgustin Garcia de Paredes, P.Eng
905-850-9003 Ext. 249
Manufacturer Reason
for Recall		The product does not meet the firm's size standards, the product was produced in the incorrect size.
FDA Determined
Cause 2		Employee error
ActionPrism 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 Commerce5 slings
DistributionWorldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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