RecallRadar

FDA Device recall Z-2490-2020

Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58…

On 2020-07-15 the FDA classified a Class II recall of Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58… by Prodimed Plastimed Division, citing lack of assurance of sterility.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2490-2020
ClassificationClass II
Statusterminated
Initiated2020-05-27
Published2020-07-15
Last updated2026-09-13 11:55 UTC
CompanyProdimed Plastimed Division
DistributionUS

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

Identifiers

code_infoAll lots within expiry

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2490-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.