| Class 2 Device Recall BC Hammock Mesh Sling | |
Date Initiated by Firm | May 23, 2013 |
Date Posted | June 19, 2013 |
Recall Status1 |
Terminated 3 on November 25, 2013 |
Recall Number | Z-1555-2013 |
Recall Event ID |
65263 |
Product Classification |
Lift, patient, non-ac-powered - Product Code FSA
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Product | BC Hammock Mesh Sling (Junior), product number, 537005.
Product Usage:
The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. |
Code Information |
Lot: PHM000524. |
Recalling Firm/ Manufacturer |
Prism Medical Services USA 45 Progress Pkwy Maryland Heights MO 63043-3701
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For Additional Information Contact | Agustin 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 |
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 | 1 sling |
Distribution | Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada. |
Total Product Life Cycle | TPLC Device Report |
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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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