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ARROW recallZ-2156-2026 · Arrow International, LLC · initiated Apr 10, 2026

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 Arrow International, 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

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 4/10/2026, recall notices were mailed to customers who were informed of the following Arrow International LLC is recalling product due to the Merit Medical Systems, Inc. recall of the Merit 16F Dual-Valved Splitable Sheath Introducer component, which is included in impacted Arrow Hemodialysis Kits & Sets. Customers were asked to do the following: 1) Users should cease use and distribution of affected product and immediately quarantine the affected product. 2) Complete and return the Acknowledgement Form, see link: https://fca.myteleflex.com/en/recall/000605 3) This notice should be passed on to all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. In addition, distributors were asked to do the following: - Provide a copy of this field safety notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you as their distributor. Should you require further information or support concerning this issue, please contact Customer Service via email ([email protected]), phone (1-866-396-2111), or FAX (1-855-419-8507).

Recall details

Recall number
Z-2156-2026
Status
Open, Classified
Initiated by the company
Apr 10, 2026
Posted by the FDA
May 13, 2026
Recalling firm
Arrow International, LLC
Quantity
285
Product code
MSD
FDA submissions
K111117
Distribution
Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW

Product description

Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

Code information (models, lots, serial numbers)

REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

31 devices cleared under K111117 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 98745).

Sources and updates

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