| Class 3 Device Recall Medivance ArcticGel Neonatal Pad |  |
Date Initiated by Firm | June 30, 2016 |
Date Posted | August 05, 2016 |
Recall Status1 |
Terminated 3 on June 06, 2017 |
Recall Number | Z-2345-2016 |
Recall Event ID |
74609 |
510(K)Number | K142702 |
Product Classification |
System, thermal regulating - Product Code DWJ
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Product | Medivance ArcticGel Neonatal Pad
The pad is designed to fit into an incubator and provide whole body cooling for patients. |
Code Information |
Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822 |
Recalling Firm/ Manufacturer |
C.R. Bard, Inc. 8195 Industrial Blvd NE Covington GA 30014-1497
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For Additional Information Contact | Jeff DeSanty 401-825-8690 |
Manufacturer Reason for Recall | An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected. |
FDA Determined Cause 2 | Other |
Action | A Customer Communication Correction Letter was sent to customers on June 30, 2016. The letter requested that they examine inventory and remove the original IFU and substitute a copy of the IFU that was included with the Correction letter. The letter also requested a sub-recall, and included a reply form which was to be completed and returned.
If you have any further questions please call (401) 825-8690. |
Quantity in Commerce | 64 |
Distribution | US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland |
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 = DWJ
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