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Presource Packs Containing Stryker StrykeFlow PS and AHTO… recallZ-3298-2026 · Cardinal Health 200, LLC · initiated Aug 18, 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 Cardinal Health 200, 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

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT: PRODUCT CORRECTION notification letter dated 8/18/26 was sent to customers. Presource has completed its investigation regarding this recall and determined that you may have received Presource kits containing the affected Stryker component(s) and lot number(s). Please reference the attached report identifying your facility s kits, along with the corresponding lot numbers that are affected by this action. If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits. 2. ALERT your clinicians of this action. 3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: [email protected] Your response to this recall notice is required Please fax this form to 614-652-9648 or email to [email protected] to acknowledge your receipt of the recall. Please respond even if you do not have recalled product on hand.

Recall details

Recall number
Z-3298-2026
Status
Open, Classified
Initiated by the company
Aug 18, 2026
Posted by the FDA
Sep 25, 2026
Recalling firm
Cardinal Health 200, LLC
Quantity
22 kits
Product code
OJF
Distribution
US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.

Product description

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC

Code information (models, lots, serial numbers)

1) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25069FG2 ; 2) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25101FG2

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 99768).

Sources and updates

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