Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry… recallZ-1404-2015 · Teleflex Medical · initiated Mar 13, 2015
Class II Terminated All recalls posted in April 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1404-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 13, 2015
- Posted by the FDA
- Apr 8, 2015
- Recalling firm
- Teleflex Medical
- Quantity
- 2,148 units
- Product code
- KDQ
- FDA submissions
- K962856
- 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 description
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
Code information (models, lots, serial numbers)
Catalogue no. S-1100-08LF, Lot no. 74F1400878
Other devices under the same FDA submission
2 devices cleared under K962856 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PLEUR-EVAC IPN028484Teleflex Incorporated · BOTTLE, COLLECTION, VACUUM29 reports
- PLEUR-EVAC IPN025424Teleflex Incorporated · BOTTLE, COLLECTION, VACUUM5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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