Recall Z-2490-2020— Prodimed Plastimed Division

Name: FDA recall Z-2490-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-27

Class II · Terminated

Class II FDA medical device recall by Prodimed Plastimed Division, initiated 2020-05-27, terminated 2021-03-29. It names one FDA 510(k) clearance: K974642. Product: Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19. Reason: Lack of assurance of sterility.

Recalling firm: Prodimed Plastimed Division
Classification: Class II
Status: Terminated
Initiated: 2020-05-27
Terminated: 2021-03-29
Firm location: Le Plessis Bouchard, France

510(k) clearances named in this recall

1 on FDA's record

K974642 — COMBICATH CATHETERPlastimed Laboratoire Pharmaceutique·cleared 1998-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.