Medical Device Recall: Z-0027-2020

FDA Recalls dataset · Firm: Merit Medical Systems, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2018-10-26 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0027-2020.

Recall Res Number
Z-0027-2020
Recalling Firm / Manufacturer
Merit Medical Systems, Inc.
FEI Number
1721504
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2018-10-26
Date Posted
N/A
Date Terminated
2020-06-12
Product Code
OES
Event Number
83738
Product Quantity
24 kits
Product Description Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Reason for Recall Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Action Details On 10/26/2018, Merit customer service representative placed telephone calls to consignees to inform them of the latex contained in the kits/trays. On 10/29/2018, the firm sent an "Urgent Product recall Notice" to all affected consignees via FedEx. The recall notification informed customers of the following: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed CRF to response@merit.com within 10 business days. 5. Please immediately return all affected lots in your possession to Merit, per the instructions found in the CRF. 6. If you have any questions concerning this communication, please contact Merit Customer service at (801) 208-4381 or by email at response@merit.com.
Distribution Pattern U.S.: VA, IL
Code Information / Serial Numbers Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05

Related Establishments / Registrations

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