Z-2491-2020Class II

Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9...

Name: Z-2491-2020 Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9...
Creator: Prodimed Plastimed Division
Published: 2020-05-27
License: https://open.fda.gov/license/

Prodimed Plastimed Division / initiated 2020-05-27 / Terminated / root cause: manufacturing process

FDA source

Prodimed Plastimed Division began a recall of Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US on 2020-05-27. FDA classified it as Class II and gives the reason as "Lack of assurance of sterility". 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-2491-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-27
Posted: 2020-07-04
Terminated: 2021-03-29
Recalling firm: Prodimed Plastimed Division
Product: Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Lack of assurance of sterility
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Prodimed notified the Distributor by phone and email on 5/27/20 stating reason for recall, health risk, and action to take: Actions to be taken: 1. Immediately examine your inventory and quarantine product subject to recall. 2. In addition, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the attached Sub-Recall communication. This recall should be carried out to the user level. 3. Send back the response form completed, dated and signed as soon as possible by email to: [email protected], or by fax: +33 23746388. 4. Make a weekly report to keep Prodimed informed of the progress of the recall. 5. After agreement of our Export Customer Service, proceed to the destruction of the recalled products quarantined (including products returned by your customers) in front of judicial officer with statement of destruction. If you have any questions, contact the customer service on the following email: [email protected] or by phone: +33 2 37 65 86 20
Quantity in commerce: 180
Distribution: Nationwide
Product codes and lots: All lots within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2491-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2487-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04
Z-2488-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04
Z-2489-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04
Z-2490-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04
Z-2491-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04
Z-2492-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04

Product code EOQ

K974642Class IICombicath CatheterPlastimed Laboratoire Pharmaceutique / cleared 1998-03-13

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)