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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion

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  Class 2 Device Recall Centurion see related information
Date Initiated by Firm February 23, 2024
Date Posted March 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1450-2024
Recall Event ID 94136
Product Classification Dilator, cervical, fixed size - Product Code HDQ
Product Centurion Manual surgical kits labeled as:
a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST;
b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST;
c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST;
d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST;
e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920;
f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930
Code Information a) HUD112ST, UDI/DI 50653160068288 (case) 00653160068283 (each), Lot Numbers: 2023032190; b) HUD12ST, UDI/DI 00653160288810 (case) 10653160288817 (each), Lot Numbers: 2023061690, 2023112990; c) HUD56ST, UDI/DI 50653160068257 (case) 00653160068252 (each), Lot Numbers: 2023112190; d) HUD910ST, UDI/DI 50653160068271 (case) 00653160068276 (each), Lot Numbers: 2023031390; e) I68920, UDI/DI 00653160351323 (case) 10653160351320 (each), Lot Numbers: 2023110290; f) I68930, UDI/DI 00653160351293 (case) 10653160351290 (each), Lot Numbers: 2023110990
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 270 units
Distribution Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Total Product Life Cycle TPLC Device Report

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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