Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE , Catalog Number: PGCGLCB11; 5) KIT, CARDIO MINIMALLY INVASIVE, Catalog Number: PV63CMST5; 6) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 7) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH; 8) ENS ENDOCHOLEYCYSTECTOMIE 4 , Catalog Number: SBA30EDCLB; 9) LAP CHOLE PACK , Catalog Number: SLC37LCJOB; 10) LAP CHOLE PACK , Catalog Number: SLC37LCJ21; 11) LAP CHOLE PACK , Catalog Number: SLC37LCJ22; 12) PACK GYNE ROBOTIC , Catalog Number: SMA30RBHSA
FDA Recall Z-3295-2026 · Posted 2026-09-25
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Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2026-08-18
Product Quantity3677 kits
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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