Class 2 Device Recall Fisherbrand

• Date Initiated by Firm: February 05, 2014
• Date Posted: April 28, 2014
• Recall Status: Terminated on August 10, 2015
• Recall Number: Z-1521-2014
• Recall Event ID: 67786
• Product Classification: Applicator, absorbent tipped, sterile - Product Code KXG
• Product: Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack; ; Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack; ; Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack; ; culture collection and industrial surfaces
• Code Information: all lots of article nos. 14-959-77, 14-959-78, 14-959-79, 14-959-81, 14-959-82, lots 60151, 61513, 61933, 62768, 63055, 60752, 61324, 62195, 63224, 60752, 62195, 61866, 62546, 8710, with expiration dates August 2014 through October 2015
• Recalling Firm/ Manufacturer: Fisher Scientific Co; 300 Industry Dr; Pittsburgh PA 15275-1001
• For Additional Information Contact: Customer Support; 412-490-4002
• Manufacturer Reason for Recall: A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab.
• FDA Determined Cause: Process control
• Action: 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
• Quantity in Commerce: 7430
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

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.