Recall Z-2562-2021 ยท EOQ Bronchoscope (Flexible Or Rigid)
Lymol Medical Corporation
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
| Date | Jul 29, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On August 9, 2021, the firm began notifying all consignees via email that the reprocessing instructions have changed. Included with each notification is a copy of the Urgent Notice, the revised IFU, and a response form. Customers were advised that the sterilization procedures were updated on November 15, 2020. Customers should discard and replace the obsolete procedures with the revised procedures included with the firm's mailing. The revised instructions have been uploaded to the LYMOL website at https://www.lymolmedical.com/instructions.cfm Customers with questions may contact the firm at |
| Quantity | 309 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.