Z-2562-2021 Class II Terminated
FDA device recall Z-2562-2021 was initiated by Lymol Medical Corporation on July 29, 2021 and is designated Class II. 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 t… The recall status is terminated (terminated October 4, 2022). Affected quantity: 309.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- October 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 309
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.
Distribution Pattern
US Nationwide distribution.
Code Information
All distributed lots