—#88132

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.

FDA product code: JSM — Culture Media, Non-Propagating Transport
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K965152
Affected lot / code info: Lot 834019, Exp 2010.10.27

Why it was recalled

Pouch may be inadequately heat sealed compromising sterility

Root cause (FDA determination)

Packaging

Action the firm took

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).

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Nationwide distribution: MI, MA, WV, CO, ME, FL, NJ, MD, WA, AZ, VA, CA, KS, IL, MO, AL, TN

Timeline

Recall initiated: 2010-01-18
Posted by FDA: 2010-03-15
Terminated: 2012-04-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88132. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.