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U.S. Department of Health and Human Services

Class 2 Device Recall remel A.C.T. II

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 Class 2 Recall
remel A.C.T. II
see related information
Date Posted March 15, 2010
Recall Status1 Terminated on April 25, 2012
Recall Number Z-1139-2010
Recall Event ID 54281
Premarket Notification
510(K) Number
K965152 
Product Classification Culture Media, Non-Propagating Transport - Product Code JSM
Product remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Lenexa, KS. Product is a sterile system recommended for use in qualitative procedures for the collection of clinical specimens and transport to the laboratory for microbiological culture of anaerobic, facultative, and aerobic organisms.
Code Information Lot 834019, Exp 2010.10.27
Recalling Firm/
Manufacturer
Remel, Inc
12076 Santa Fe Trail Dr
Lenexa, Kansas 66215-3519
For Additional Information Contact Debbie Wyatt
913-895-4075
Manufacturer Reason
for Recall
Pouch may be inadequately heat sealed compromising sterility
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action An IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" dated January 18, 2010, was sent to customers via regular mail. The notice described the product, problem, and action to be taken by the customers. The customers are requested to: review their inventory for the indicated product, discard all remaining units of the product lot, complete the "Product Inventory Checklist" enclosed to report the amount of product they wanted replaced or credited, and return by February 1, 2010 regardless if they have affected product and/or have verbally contacted the firm. If you have any inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 (USA) or 913-888-0930 (International).
Quantity in Commerce 154/10-unit packages
Distribution Nationwide distribution: MI, MA, WV, CO, ME, FL, NJ, MD, WA, AZ, VA, CA, KS, IL, MO, AL, TN
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.
510(K) Database 510(K)s with Product Code = JSM and Original Applicant = REMEL CO.
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