Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Summary
The FDA issued a Class II for Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G by Cook Biotech, Inc.. Reason: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products..
Details
Source
Device Recall
External ID
Z-0832-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Lot/Code Info: Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
Quantity Affected: 49 devices
Reason for Recall
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Distribution
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-22
Company
W Lafayette, IN
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 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Biotech, Inc. has 15 FDA actions in our database, including 15 recalls.
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 (Cook Biotech, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Biotech, Inc. have FDA actions?
Cook Biotech, Inc. has 15 FDA actions in our database, including 15 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0832-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29