Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medline Convenience Kits containing the ConMed/Unimax Detachable Endo

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Medline Convenience Kits containing the ConMed/Unimax Detachable Endosee related information
Date Initiated by FirmAugust 28, 2024
Date PostedOctober 10, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0053-2025
Recall Event ID 95338
Product Classification laparoscopy kit - Product Code FDE
ProductMedline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Code Information Lot numbers 24AMA209, exp. 2025-06-30; 24BMB025, exp. 2025-08-31; 23LMA745, exp. 2025-07-31; UDI-DI each 10195327384494, UDI-DI case-40195327384495
FEI Number 1417592
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
886-359-1704
Manufacturer Reason
for Recall		CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionThe recalling firm issued letters on and dated 8/28/2024 via first class mail and email. The letter explained the reason for recall and instructed the customer that nothing was to be returned to Medline. The customer is to request a sticker to be placed on affected kits instructing the user to remove the recalled component. The consignee is required to immediately check their stock for the affected item number and affected lot numbers which can be located within the recall portal and quarantine all affected product immediately. The consignee is to use the link and information in the letter to complete their response form. They are to list the quantity of affected product in inventory on the form and submit the form. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory with instructions for the user to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight. If the consignee is a distributor or has resold or transferred the product to another company or individual, the consignee is to notify their downstream customers of this communication.
Quantity in Commerce72 kits
DistributionUS Nationwide distribution in the state of CA.
Total Product Life CycleTPLC 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.
-
-