Retiro De Equipo (Recall) de Device Recall Paraffin Wax

Recall

73334

Class 3

Z-1319-2016

2016-02-16

Terminated

United States

2016-08-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144179

Multiple complaints were received from customers indicating that they ordered product 8335(type 3 paraffin) but when they opened the box, they found product 8336 (type 6 paraffin) inside.

ThermoFisher sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 15, 2016, to all affected customers. The letter contained the following instructions: If you have the above lot in your possession, please determine whether the bags are labeled as Type 3 (PN 8335) or Type 6 (PN 8336). ¿ If the product is labeled as Type 3 (PN 8335) please complete the attached Response form with the quantity in inventory and return the form to Richard-Allan Scientific. The product may be used and no further action is required. ¿ If the product is labeled as Type 6 (PN 8336) please complete the attached Response form with the quantity in inventory. The product may be used as is or returned to Richard-Allan Scientific. Please indicate on the Response form if the product will be used or a return is desired. Return the completed form to Richard-Allan Scientific. ¿ If affected product has been used previously, please complete the attached Response form with the quantity that was used. No further action is required. By returning the attached Acknowledgment Form will facilitate reporting of this matter to the FDA. Customers with questions were instructed to call 269-544-5628.