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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmJune 27, 2024
Date PostedSeptember 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3111-2024
Recall Event ID 95128
Product Classification Endoscope introducer kit - Product Code NWU
ProductMedline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pack Number DYKE1356; c) ENDOSCOPY KIT, Pack Number DYKE1771C
Code Information a) DYKE1355: UDI/DI case 40889942274193, UDI/DI each 10889942274192; Lot Numbers: 23LBB043, 24BBJ327, 24CBS751; b) DYKE1356: UDI/DI case 40889942274186, UDI/DI each 10889942274185; Lot Numbers: 23LBD062, 24ABA646, 24BBJ328, 24CBG449, 24DBE106, 24EBG238; c) DYKE1771C: UDI/DI case 40195327331994, UDI/DI each 10195327331993; Lot Numbers: 24ABX292
FEI Number 1417592
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
FDA Determined
Cause 2		Process control
ActionMedline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce6257 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Panama.
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.
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