LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000,
Summary
The FDA issued a Class II for LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, by Lymol Medical Corporation. Reason: Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions w.
Details
Source
Device Recall
External ID
Z-2562-2021
Action Date
2021-10-06
Status
Terminated
Category
device
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
Lot/Code Info: All distributed lots
Quantity Affected: 309
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
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-29
Company
Woburn, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lymol Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lymol Medical Corporation have FDA actions?
This is the only FDA action we have on record for Lymol Medical Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2562-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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