Z-2488-2020 Class II Terminated

Recalled by Prodimed Plastimed Division — Le Plessis Bouchard

FDA device recall Z-2488-2020 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: 39800.

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
39800

Product description

Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US

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-2488-2020
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.

Source: openFDA record for Z-2488-2020. Report a data issue: hello@regdatalab.com.