Device Recall Fisherbrand 의 리콜

Recall

67786

Class 2

Z-1521-2014

2014-02-05

2014-04-28

Terminated

United States

2015-08-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126325

A customer reported the presence of an organism in a lot of calcium alginate fiber tipped wood applicator swab.

Fisher Scientific sent an Urgent: Medical Device Recall/Return letter dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS TO BE TAKEN BY THE USER OR DISTRIBUTOR: Fisher Scientific requests that you discontinue use and distribution of all products referenced above. We also request that you return all product (opened and unopened) as soon as possible. A credit will be issued for returned product. User: Fisher Scientific requests that you complete the Acknowledgment Form enclosed with this letter, even if you do not have the above mentioned product(s) in your inventory, within three (3) working days. Distributor: Our records indicate that you may have purchased one or more of the above products for re-sale to your customers. You should complete the attached Acknowledgment Form for inventory you have received and/or which is still in stock. Fisher Scientific requests that you complete and return the Acknowledgment Form enclosed with this letter, even if you do not have the above mentioned catalog numbers in your inventory, within three (3) working days. In addition, please contact your affected customer base to advise them of the expanded recall, by providing them with a copy of this letter. You should insert your contact information, email and fax numbers in the Acknowledgment Form and request that your customer return the Acknowledgment Form to you, and you notify us of the information conveyed in such Acknowledgment Form(s). ACTION BY FISHER SCIENTIFIC: Fisher Scientific has no inventory of the affected products as it was discontinued in May 2013. However, we do have alternative products that we can recommend as replacements. Please contact customer service for information on product alternatives. We appreciate your immediate attention to this expanded voluntary recall. By returning the attached Acknowledgment Form you wil