Recall Z-0417-2018 ยท OUW Infant Positioner, Rx, Use In Highly Monitored Setting
Molnlycke Health Care, Inc
9x15" Medium Utility Positioner with Cover
| Date | Jul 26, 2017 |
| Status | Terminated |
| Reason | Products may not meet specifications due to possible presence of metal shavings. |
| Root cause | Under Investigation by firm |
| 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. |
| Quantity | 204 units total |
| Distribution | Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.