Z-3298-2026

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

Name: Z-3298-2026 Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Creator: Cardinal Health 200, LLC
Published: 2026-08-18
License: https://open.fda.gov/license/

Cardinal Health 200, LLC / initiated 2026-08-18 / Open, Classified

FDA source

Recall record

Recall number: Z-3298-2026
Status: Open, Classified
Initiated: 2026-08-18
Posted: 2026-09-25
Recalling firm: Cardinal Health 200, LLC
Product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Product code: OJF Hysterectomy Kit
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 22 kits
Distribution: US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
Product codes and lots: 1) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25069FG2 ; 2) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25101FG2

Product code OJF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)