Z-2643-2020Class II

LoFric Origo, Nelaton, 16in, FR10 urinary catheters

Name: Z-2643-2020 LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Creator: Wellspect HealthCare (Division of DENTSPLY IH AB)
Published: 2020-06-17
License: https://open.fda.gov/license/

Wellspect Healthcare / initiated 2020-06-17 / Terminated / root cause: manufacturing process

FDA source

Wellspect HealthCare (Division of DENTSPLY IH AB) began a recall of LoFric Origo, Nelaton, 16in, FR10 urinary catheters on 2020-06-17. FDA classified it as Class II and gives the reason as "Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip". 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-2643-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-17
Posted: 2020-07-17
Terminated: 2021-04-09
Recalling firm: Wellspect Healthcare
Product: LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Product code: EZD Catheter, Straight
Reason for recall: Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Effected catheters must be not used and should be immediately returned. Wellspect issued an urgent medical device field notice dated June 19, 2020 to customers.
Distribution: AL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, VA and Australia, Brazil, Canada, European Union, China, South Korea, Kuwait, New Zeeland, Singapore, United Kingdom
Product codes and lots: Lot # 447123

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2643-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2643-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-17
Z-2644-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-17
Z-2645-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-17

Product code EZD

K122078Class IILofric Primo, Lofric Hydro-KitAstra Tech, Inc. / cleared 2012-10-31

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)