Home / Recalls / Prodimed Plastimed Division / Z-2491-2020

Z-2491-2020 Class II Terminated

Recalled by Prodimed Plastimed Division — Le Plessis Bouchard

FDA device recall Z-2491-2020 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: 180.

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: 180

Product description

Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US

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-2491-2020
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.

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