Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
FDA Recall Z-1404-2015 · Posted 2015-04-08
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeKDQ
Date Initiated2015-03-13
Date Terminated2017-08-14
Product Quantity2,148 units
Reason for Recall
Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
Firm Action
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.
Root Cause
Other
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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