| | Class 2 Device Recall |  |
| Date Initiated by Firm | July 26, 2017 |
|---|
| Create Date | January 26, 2018 |
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| Recall Status1 |
Terminated 3 on April 06, 2021 |
| Recall Number | Z-0416-2018 |
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| Recall Event ID |
78058 |
| Product Classification |
Infant Positioner, Rx, Use In Highly Monitored Setting - Product Code OUW
|
| Product | 7x10" Small Utility Positioner with Cover |
|---|
| Code Information |
Recorder Code 1400227 |
Recalling Firm/
Manufacturer |
Molnlycke Health Care, Inc
5550 Peachtree Pkwy Ste 500
Norcross GA 30092-2555
|
| For Additional Information Contact |
470-250-7952 |
|---|
Manufacturer Reason
for Recall | Products may not meet specifications due to possible presence of metal shavings. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Customers were notified by letter via overnight mail on approximately 07/26/2017. Instructions include identify and quarantine affected product in inventory, contact Molnlycke to arrange return of affected product, and complete and return the Acknowledgement Form. |
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| Quantity in Commerce | 960 units total |
|---|
| Distribution | Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI. |
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| 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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