CLASS II Device recall · Reported 15 Apr 2015 · FDA Enforcement Report
Pluer-evac Sahara Chest Drainage System, S-1100-08LF recalled
Teleflex Medical is recalling Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, distributed in 24 states. The recall was initiated on 13 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1404-2015
- FDA event ID
- 70723
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2015
- FDA classified
- 8 Apr 2015
- Reported
- 15 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 13 Mar 2015 | Recall initiated by company | |
| 8 Apr 2015 | Classified by FDA | +26 days |
| 15 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
Where it was distributed
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.
AlaskaAlabamaArkansasCaliforniaColoradoFloridaGeorgiaIllinoisIndianaKansasKentuckyMassachusettsMarylandMichiganMinnesotaNew YorkOhioPennsylvaniaRhode IslandSouth Carolina
Questions about this recall
Why was it recalled?
Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
Which lots are affected?
Catalogue no. S-1100-08LF, Lot no. 74F1400878
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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