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Palindrome recallZ-1887-2025 · Mozarc Medical US LLC · initiated Apr 23, 2025

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 Mozarc Medical US LLC 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

Potential breach of sterile barrier packaging.

FDA root cause category: Packaging

What the company is doing

An URGENT: MEDICAL DEVICE RECALL notification dated April 2025 was mailed to consignees on 4/23/25. This notification recommends that clinicians follow facility-specific policies and procedures for routine assessment of the hemodialysis access device for patency, function, and efficacy, as well as for monitoring patient status. Consignees are instructed to immediately quarantine and discontinue use of affected devices in inventory. Consignees are to complete the electronic Customer Confirmation form to facilitate obtaining a Return Goods Authorization number for recalled devices to be returned for credit or replaced. Product purchased through a distributor can be arranged through the distributor. Consignees with any questions about the Customer Confirmation form can contact IQVIA by phone at 1-256-680-9942 or by email at [email protected]. Consignees with questions about the recall can contact Medtronic Customer Care at 877-211-1850.

Recall details

Recall number
Z-1887-2025
Status
Open, Classified
Initiated by the company
Apr 23, 2025
Posted by the FDA
May 30, 2025
Recalling firm
Mozarc Medical US LLC
Quantity
95,938 units
Product code
MSD
FDA submissions
K123196
Distribution
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.

Product description

Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Code information (models, lots, serial numbers)

Model No.8888133508P, 8888123408P, 8888119368P, 8888128458P; UDI: 20884521157931, 20884521157795, 20884521157726, 20884521157863; Serial No. 2234800132, 2302500141, 2302500148, 2305300142, 2305300144, 2305300177, 2313800083, 2324100168, 2324100310, 2324100311, 2405800229, 2426300218, 2426700122, 2427700199.

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

66 devices cleared under K123196 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96809).

Sources and updates

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