Z-0846-2019Class II

Pilling COOLEY SUMP-SUCTION TUBE, REF 351547

Name: Z-0846-2019 Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Creator: Teleflex Medical
Published: 2019-01-07
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-01-07 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Pilling COOLEY SUMP-SUCTION TUBE, REF 351547 on 2019-01-07. FDA classified it as Class II and gives the reason as "The internal tip is missing from the device, causing the device to not function as intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0846-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-07
Posted: 2019-02-16
Terminated: 2021-11-04
Recalling firm: Teleflex Medical
Product: Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Product code: JOL Catheter And Tip, Suction
Reason for recall: The internal tip is missing from the device, causing the device to not function as intended.
Root cause tag: manufacturing process
FDA 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 in commerce: 80 units
Distribution: TX, NY, DC and Philippines
Product codes and lots: Lot/Batch Numbers: A8, C8, I7

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0846-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0846-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-16

Product code JOL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)