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1500ml Soft Liner, 1/4x6 Tbg Ns, Ref Or926k recallZ-2696-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 22, 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

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.

Recall details

Recall number
Z-2696-2024
Status
Open, Classified
Initiated by the company
Mar 22, 2024
Posted by the FDA
Aug 22, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product code
KDQ
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Product description

1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K

Code information (models, lots, serial numbers)

UDI/DI 40888277276223 (package), 10888277276222 (unit), Lot Numbers: 670220510, 670220607, 670220607, 670220701, 670220701, 670220701, 670220727, 670220721, 670220727, 670220727, 670220825, 670220825, 670221115, 670220915, 670220825, 670220915, 670220915, 670220928, 670220928, 670220928, 670221024, 670220928, 670221024, 670221220, 670221220, 670221124, 670221124, 670221213, 670221202, 670221202, 670221222, 670221222, 670221222, 670230206, 670230206, 670230215, 670230417, 670230331, 670230417, 670230508, 670230922, 670230922, 670231019, 670231101, 670231101, 670231123, 670231123, 670231116, 670231205

Devices named in this recall

1 device 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 94356).

Sources and updates

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