Skip to content

Medline convenience kits containing semi-rigid suction… recallZ-3121-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Jun 27, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company is doing

Medline 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 [email protected].

Recall details

Recall number
Z-3121-2024
Status
Open, Classified
Initiated by the company
Jun 27, 2024
Posted by the FDA
Sep 11, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1076 units
Product code
OJH
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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

Devices named in this recall

22 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95128).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page