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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-3114-2024
Recall Event ID 95128
Product Classification General surgery tray - Product Code LRO
ProductMedline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666; c) SUCTION CANISTER KIT, Pack Number DYKM2196; d) SUCTION CANISTER KIT, Pack Number DYKM2196H; e) BRONCH LAB PACK-LF, Pack Number DYNJ24810B; f) THORACIC, Pack Number DYNJ907991F; g) RECTAL, Pack Number DYNJ908108A; h) ROBOTIC, Pack Number DYNJ908109C; i) CERVICAL, Pack Number DYNJ908748D; j) LAMI, Pack Number DYNJ908750D; k) MERCY TIFFIN BASIC-LF, Pack Number DYNJ909731; l) MERCY TIFFIN LITHOTOMY, Pack Number DYNJ909735; m) BASIC GENERAL SET UP, Pack Number DYNJ909945; n) BASIC GENERAL SET UP, Pack Number DYNJ909945A; o) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289; p) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289H; q) MTHZ TOTAL HIP, Pack Number DYNJC9311M; r) BRONCH KIT, Pack Number P906877
Code Information a) DYKE1092B: UDI/DI case 40889942777366, UDI/DI each10889942777365, Lot Numbers: 24BBK418, 24DBH210; b) DYKE1666: UDI/DI case 40193489708487, UDI/DI each10193489708486, Lot Numbers: 24ADB503, 24CDA282, 24CDB279, 24DDB221, 24EDA406; c) DYKM2196: UDI/DI case 40195327236916, UDI/DI each10195327236915, Lot Numbers: 23LBF762, 24BBB541, 24CBI973, 24DBH448; d) DYKM2196H: UDI/DI case 40195327236916, UDI/DI each10195327236915, Lot Numbers: 23LBF762, 24BBB541, 24CBI973, 24DBH448; e) DYNJ24810B: UDI/DI case 40889942440611, UDI/DI each10889942440610, Lot Numbers: 24CBE214; f) DYNJ907991F: UDI/DI case 40195327641468, UDI/DI each10195327641467, Lot Numbers: 24DLA042, 24DLA594; g) DYNJ908108A: UDI/DI case 40195327507153, UDI/DI each10195327507152, Lot Numbers: 24BBK532; h) DYNJ908109C: UDI/DI case 40195327507238, UDI/DI each10195327507237, Lot Numbers: 23LBT867, 24BBA187, 24DBI723, 24FBA058; i) DYNJ908748D: UDI/DI case 40195327549207, UDI/DI each10195327549206, Lot Numbers: 23LBE394, 24CBD863; j) DYNJ908750D: UDI/DI case 40195327549214, UDI/DI each10195327549213, Lot Numbers: 24FBC284; k) DYNJ909731: UDI/DI case 40195327464524, UDI/DI each10195327464523, Lot Numbers: 24ABU492; l) DYNJ909735: UDI/DI case 40195327464685, UDI/DI each10195327464684, Lot Numbers: 23LBH989, 24ABV099, 24CBG700; m) DYNJ909945: UDI/DI case 40195327512669, UDI/DI each10195327512668, Lot Numbers: 24ABV895; n) DYNJ909945A: UDI/DI case 40195327615803, UDI/DI each10195327615802, Lot Numbers: 24DBA530; o) DYNJ910289: UDI/DI case 40195327618675, UDI/DI each10195327618674, Lot Numbers: 24CBC847; p) DYNJ910289H: UDI/DI case 40198459012489, UDI/DI each10198459012488, Lot Numbers: 24CBC847; q) DYNJC9311M: UDI/DI case 40198459012489, UDI/DI each10198459012488, Lot Numbers: 24FDA111; r) P906877: UDI/DI case 40889942002581, UDI/DI each10889942002580, Lot Numbers: 24FDA021
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 Commerce3117 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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