Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS98
Summary
The FDA issued a Class II for Medline convenience kits containing semi-rigid suction liners labeled as follows by MEDLINE INDUSTRIES, LP - Northfield. Reason: 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 0.
Details
Source
Device Recall
External ID
Z-3121-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D; c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F; d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C; e) LAMINECTOMY, Pack Number DYNJ908091B; f) PODIATRY, Pack Number DYNJ908092C; g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B; h) CRANI, Pack Number DYNJ908097A; i) HIP PINNING, Pack Number DYNJ908102B; j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B; k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B; m) HAND-LF, Pack Number DYNJ908425; n) TOTAL JOINT, Pack Number DYNJ908660A; o) MERCY TIFFIN HAND, Pack Number DYNJ909734; p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738; q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740; r) ACL-WHSC, Pack Number DYNJ910074A; s) EXTREMITY-WHSC, Pack Number DYNJ910077; t) EXTREMITY-WHSC, Pack Number DYNJ910077A; u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A; v) MICRODISC, Pack Number DYNJ910370; w) MTHZ TOTAL HIP, Pack Number DYNJC9311L
Lot/Code Info: a) CDS981510L: UDI/DI case 40195327195435, UDI/DI each 10195327195434, Lot Numbers: 23LDB386, 23LDB793; b) DYNJ900720D: UDI/DI case 40193489951593, UDI/DI each 10193489951592, Lot Numbers:23LBT897; c) DYNJ900720F: UDI/DI case 40195327635337, UDI/DI each 10195327635336, Lot Numbers: 24CBC838, 24EBH235; d) DYNJ908090C: UDI/DI case 40195327507245, UDI/DI each 10195327507244, Lot Numbers: 24CBH612, 24FBA023; e) DYNJ908091B: UDI/DI case 40195327507023, UDI/DI each 10195327507022, Lot Numbers: 24CBK626; f) DYNJ908092C: UDI/DI case 40195327507030, UDI/DI each 10195327507039, Lot Numbers: 23LBU932, 24ABT063, 24CBP714; g) DYNJ908095B: UDI/ DI case 40195327507184, UDI/DI each 10195327507183, Lot Numbers: 24ABO437, 24ABW989, 24EBH236; h) DYNJ908097A: UDI/DI case 40195327507078, UDI/DI each 10195327507077, Lot Numbers:23LBV779, 24CBU878; i) DYNJ908102B: UDI/DI case 40195327507191, UDI/DI each 10195327507190, Lot Numbers: 24BBI407; j) DYNJ908103B: UDI/DI case 40195327507108, UDI/DI each 10195327507107, Lot Numbers: 24CBO655; k) DYNJ908110B: UDI/DI case 40195327507160, UDI/DI each 10195327507169, Lot Numbers: 24ABS361, 24CBE409; m) DYNJ908425: UDI/DI case 40195327072613, UDI/DI each 10195327072612, Lot Numbers: 24ABL204; n) DYNJ908660A: UDI/DI case 40195327219674, UDI/DI each 10195327219673, Lot Numbers: 23LMC113, 24AME301, 24AMJ018, 24CMH075; o) DYNJ909734: UDI/DI case 40195327464708, UDI/DI each 10195327464707, Lot Numbers: 24ABA222, 24CBO720; p) DYNJ909738: UDI/DI case 40195327464739, UDI/DI each 10195327464738, Lot Numbers: 24ABY029, 4EBH232; q) DYNJ909740: UDI/DI case 40195327464753, UDI/DI each 10195327464752, Lot Numbers: 24BBK598; r) DYNJ910074A: UDI/DI case 40195327639281, UDI/DI each 10195327639280, Lot Numbers: 24CBA353; s) DYNJ910077: UDI/DI case 40195327568383, UDI/DI each 10195327568382, Lot Numbers: 23LBS081; t) DYNJ910077A: UDI/DI case 40195327639342, UDI/DI each 10195327639341, Lot Numbers: 24CBM378, 24DBC165; u) DYNJ910080A: UDI/DI case 40195327639304, UDI/DI each 10195327639303, Lot Numbers: 24BBS375; v) DYNJ910370: UDI/DI case 40195327654536, UDI/DI each 10195327654535, Lot Numbers: 24DDB322, 24EDA091; w) DYNJC9311L: UDI/DI case 40195327464777, UDI/DI each 10195327464776, Lot Numbers: 24CDC175
Quantity Affected: 1076 units
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-27
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3121-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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