CLASS II Device recall · Reported 27 Feb 2019 · FDA Enforcement Report
Pilling Cooley Sump-suction Tube recalled by Teleflex Medical
Teleflex Medical is recalling Pilling Cooley Sump-suction Tube, distributed in District of Columbia, New York, Texas. The recall was initiated on 7 Jan 2019 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-0846-2019
- FDA event ID
- 81918
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2019
- FDA classified
- 16 Feb 2019
- Reported
- 27 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Jan 2019 | Recall initiated by company | |
| 16 Feb 2019 | Classified by FDA | +40 days |
| 27 Feb 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The internal tip is missing from the device, causing the device to not function as intended.
Product as listed by the FDA
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Where it was distributed
TX, NY, DC and Philippines
Questions about this recall
Why was it recalled?
The internal tip is missing from the device, causing the device to not function as intended.
Which lots are affected?
Lot/Batch Numbers: A8, C8, I7
Where was it sold?
TX, NY, DC and Philippines
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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