Home / Recalls / Prodimed Plastimed Division / Z-2490-2020

Z-2490-2020 Class II Terminated

Recalled by Prodimed Plastimed Division — Le Plessis Bouchard

FDA device recall Z-2490-2020 was initiated by Prodimed Plastimed Division on May 27, 2020 and is designated Class II. Reason for recall: Lack of assurance of sterility The recall status is terminated (terminated Mar 29, 2021). Affected quantity: 1460.

Recall details

Product Type: Devices
Report Date: Jul 15, 2020
Initiation Date: May 27, 2020
Termination Date: Mar 29, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1460

Product description

Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19

Reason for recall

Lack of assurance of sterility

Distribution pattern

Nationwide

Code information

All lots within expiry

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2490-2020
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Prodimed Plastimed Division

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Z-2492-2020 Class II — Prodimed Combicath Paediatric catheters for blind protected distal bronchial… (May 27, 2020)
Z-2487-2020 Class II — Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE… (May 27, 2020)
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