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U.S. Department of Health and Human Services

Class 3 Device Recall Remel BactiSwab NPG

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  Class 3 Device Recall Remel BactiSwab NPG see related information
Date Initiated by Firm May 07, 2009
Date Posted August 18, 2009
Recall Status1 Terminated 3 on January 15, 2010
Recall Number Z-1812-2009
Recall Event ID 52160
Product Classification Specimen Collection Device - Product Code LIO
Product Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS.

Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate.
Code Information Lot 725080, Exp. 2013.05.28
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Debbie Wyatt
913-895-4075
Manufacturer Reason
for Recall		 Incorrect expiration date on the product
FDA Determined
Cause 2		 Incorrect or no expiration date
Action The recalling firm issued Important Medical Device Product Recall Notice letters dated 5/7/09 via regular mail to their direct accounts explaining the reason for recall and requesting they discard all remaining units of the affected lot number in their inventory. A Product Inventory Checklist was enclosed to be returned in the enclosed self-addressed, stamped envelope to report the amount of product that was discarded. The Technical Services Department should be contacted at 800-447-3641 if there are any inquiries concerning the letter.
Quantity in Commerce 103 packages
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.
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