U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
culture media, non-propagating transport - Product Code JSM
원인
Pouch may be inadequately heat sealed compromising sterility.
조치
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).
Nationwide distribution: MI, MA, WV, CO, ME, FL, NJ, MD, WA, AZ, VA, CA, KS, IL, MO, AL, TN
제품 설명
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.