Z-1404-2015Class II

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

Name: Z-1404-2015 Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical
Creator: Teleflex Medical
Published: 2015-03-13
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-03-13 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical on 2015-03-13. FDA classified it as Class II and gives the reason as "Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1404-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Posted: 2015-04-08
Terminated: 2017-08-14
Recalling firm: Teleflex Medical
Product: Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 2,148 units
Distribution: 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.
Product codes and lots: Catalogue no. S-1100-08LF, Lot no. 74F1400878

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1404-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1404-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-08

Product code KDQ

K962856Class IIPleur-Evac Sahara Adult/pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model S-100 AutotrDeknatel, Inc. / cleared 1996-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)