Recall Z-2562-2021— Lymol Medical Corporation

Name: FDA recall Z-2562-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-29

Class II · Terminated

Class II FDA medical device recall by Lymol Medical Corporation, initiated 2021-07-29, terminated 2022-10-04. FDA's recall record names no specific 510(k) clearance for this event. Product: LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420. Reason: Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the revision..

Recalling firm: Lymol Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-07-29
Terminated: 2022-10-04
Firm location: Woburn, MA, United States

Product description

LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420

Reason for recall

Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the revision.

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