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U.S. Department of Health and Human Services

Class 2 Device Recall Fisherbrand Sterile Swabs

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 Class 2 Recall
Fisherbrand Sterile Swabs
see related information
Date Posted August 12, 2013
Recall Status1 Open
Recall Number Z-1955-2013
Recall Event ID 65822
Product Classification Applicator, Absorbent Tipped, Sterile - Product Code KXG
Product Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.
Code Information Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08.
Recalling Firm/
Manufacturer
Fisher Scientific Co
300 Industry Dr
Pittsburgh, Pennsylvania 15275-1001
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Fisher Scientific Co. Customer Service
724-517-1500
Manufacturer Reason
for Recall
The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Customers were notified by letter on June 18, 2013 and requested to discontinue use and return all affected product. The firm also asked that any additional affected customer base be contacted and notified of the recall if the lots had been further distributed. If you have any questions, contact Stericycle (reference "Event 4070") at 1-877-410-5558.
Quantity in Commerce 1230
Distribution Nationwide and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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