FDA Medical Device Recalls (openFDA)
Teleflex Medical: Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
- Recall number
- Z-0846-2019
- Recalling firm
- Teleflex Medical
- Product
- Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
- Status
- Terminated
- Initiated
- 2019-01-07
- Posted
- not on file
- Terminated
- 2021-11-04
- Reason
- The internal tip is missing from the device, causing the device to not function as intended.
- Root cause
- Nonconforming Material/Component
- Action
- The firm initiated the recall by letter on 01/07/2019. The firm requested the return of the units.
- Quantity
- 80 units
- Distribution
- TX, NY, DC and Philippines
- Lot, serial or model codes
- Lot/Batch Numbers: A8, C8, I7
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JOL
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28