| Class 2 Device Recall Centurion | |
Date Initiated by Firm | February 23, 2024 |
Date Posted | March 29, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1443-2024 |
Recall Event ID |
94136 |
Product Classification |
Tray, surgical - Product Code LRP
|
Product | Centurion manual surgical kits labeled as:
a) STERILE ALLIS TISS FCP 10", Product Code I68905;
b) VAGINAL REPAIR KIT, Product Code MNS11505;
c) PTCA ADD-ON KIT, Product Code MNS11545;
d) INSTRUMENT SET, Product Code SUT21355 |
Code Information |
a) I68905, UDI/DI 00653160350944 (case) 10653160350941 (each), Lot Numbers: 2023012590, 2023042590;
b) MNS11505, UDI/DI 00653160320213 (case) 10653160320210 (each), Lot Numbers: 2023022490, 2023071390;
c) MNS11545, UDI/DI 00653160320305 (case) 10653160320302 (each), Lot Numbers: 2023021390;
d) SUT21355, UDI/DI 00653160329223 (case) 10653160329220 (each), Lot Numbers: 2023060790
|
Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
|
For Additional Information Contact | Karin Johnson 886-359-1704 |
Manufacturer Reason for Recall | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
FDA Determined Cause 2 | Process control |
Action | Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers. |
Quantity in Commerce | 1335 units |
Distribution | Worldwide distribution - US Nationwide and the countries of Panama, Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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