—#134560

Product

Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

FDA product code: KDQ — Bottle, Collection, Vacuum
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K962856
Affected lot / code info: Catalogue no. S-1100-08LF, Lot no. 74F1400878

Why it was recalled

Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

Root cause (FDA determination)

Other

Action the firm took

Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any of the affected listed catalog numbers and to return the product. Complete the enclosed acknowledgement form to Teleflex Medical. The form is to be returned even if they have not products. For further questions contact your local sales representative or Customer Service at 1-866 246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: US Distribution to the states of : AK, AL, AR, CA, CO, FL, GA, IL, IN, KY, KS, MA, MD, MI, MN, NY, OH, PA, RI, SC, TX, VA WI and WV.

Timeline

Recall initiated: 2015-03-13
Posted by FDA: 2015-04-08
Terminated: 2017-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.