| Class 2 Device Recall Physician Engineered Products, Inc | |
Date Initiated by Firm | August 31, 2013 |
Date Posted | August 31, 2015 |
Recall Status1 |
Terminated 3 on September 02, 2015 |
Recall Number | Z-2486-2015 |
Recall Event ID |
71803 |
510(K)Number | K110550 |
Product Classification |
Unit, neonatal phototherapy - Product Code LBI
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Product | Bright Embrace, a Single Bili Light for newborn phototherapy
Distributed by: Physician Engineered Products, Inc., Model SBL60 |
Code Information |
Serial Numbers: 1002565 1002579 1002632 1002644 1002655 1002688 1002689 1002736 1002746 1002753-1002762 (10 units) 1002768-1002788 (21 units) 1002791-1002805 (15 units) 1002807-1002813 (7 units) 1002816-1002823 (8 units) 1002825-1002833 (9 units) 1002835-1002836 (2 units) 1002850-1002865 (16 units) |
Recalling Firm/ Manufacturer |
Physician Engineered Products, Inc. 103 Smith St Fryeburg ME 04037-1182
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For Additional Information Contact | 207-935-1256 |
Manufacturer Reason for Recall | Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions |
FDA Determined Cause 2 | Device Design |
Action | Physician Engineered Products, Inc. sent an Bright Embrace Recall notification dated September 10, 2013, to notify customers of the recall of the Bright Embrace .
PEP is issuing a Return Authorization to you. Upon receipt PEP will reimburse to you:
1) The cost of the device(s)
2) Shipping costs-both from and to PEP
For further questions please call (207) 935-1256. |
Quantity in Commerce | 97 units |
Distribution | Worldwide Distribution - US Distribution to the states of : CA, CO, FL, KY, MA, MD, NM, PA, TN, TX and VA., and to the countries of : Egypt, Honduras, Saudi Arabia and Singapore. |
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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510(K) Database | 510(K)s with Product Code = LBI
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