Recalls / —
—#170297
Product
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
- FDA product code
- JOL — Catheter And Tip, Suction
- Device class
- Class 2
- Medical specialty
- General Hospital
- Affected lot / code info
- Lot/Batch Numbers: A8, C8, I7
Why it was recalled
The internal tip is missing from the device, causing the device to not function as intended.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
The firm initiated the recall by letter on 01/07/2019. The firm requested the return of the units.
Recalling firm
- Firm
- Teleflex Medical
- Address
- 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186
Distribution
- Distribution pattern
- TX, NY, DC and Philippines
Timeline
- Recall initiated
- 2019-01-07
- Terminated
- 2021-11-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #170297. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.