| | Class 2 Device Recall Presource Packs |  |
| Date Initiated by Firm | July 29, 2026 |
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| Date Posted | September 03, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3095-2026 |
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| Recall Event ID |
99553 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD;
2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC;
3) KIT, PRIMARY RESECTION , Catalog Number: PGVMOTBB19;
4) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26;
5) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26;
6) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGV2LTNHN;
7) KIT,UMMC GENERAL MAJOR TRANSPL, Catalog Number: PG15OT92A;
8) KIT,MAJOR LITHOTOMY NEW HAN , Catalog Number: PG23MLNLD;
9) KIT, GENDER CARE , Catalog Number: PG29GCPCK;
10) KIT, GENDER CARE , Catalog Number: PG29GCPC3;
11) KIT, MUH LIVER , Catalog Number: PG33LVMNC;
12) KIT, MIS HERNIA , Catalog Number: PG35HPBJK;
13) KIT, GENERAL MAJOR , Catalog Number: PG43MJEJD;
14) KIT, OPEN THORACOTOMY CMC , Catalog Number: PVCGOTACF;
15) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYB;
16) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYC;
17) KIT, HEART II , Catalog Number: PV23HEVAE;
18) KIT, FLAP ACCESSORY , Catalog Number: PW35FABJE;
19) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG;
20) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH |
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| Code Information |
1) PBCCGRSGD, UDI-DI: 10197106840085(each), 50197106840083(case), Lot Number: NGKU0957 ;
2) PB35GYBJC, UDI-DI: 10197106375723(each), 50197106375721(case), Lot Number: NGKU2052 ;
3) PGVMOTBB19, UDI-DI: 10198956264113(each), 50198956264111(case), Lot Number: NGKT2394 ;
4) PGVM07C26, UDI-DI: 10198956264434(each), 50198956264432(case), Lot Number: NGKT2394 ;
5) PGVM07C27, UDI-DI: 10198956292895(each), 50198956292893(case), Lot Number: NGKT2394 ;
6) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV2390 ;
7) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV3390 ;
8) PG15OT92A, UDI-DI: 10197106475041(each), 50197106475049(case), Lot Number: NGKW2883 ;
9) PG23MLNLD, UDI-DI: 10198956432024(each), 50198956432022(case), Lot Number: NGKU3969 ;
10) PG29GCPCK, UDI-DI: 10198956299207(each), 50198956299205(case), Lot Number: NGKU4716 ;
11) PG29GCPC3, UDI-DI: 10198956532496(each), 50198956532494(case), Lot Number: NGKU4716 ;
12) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ;
13) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ;
14) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ;
15) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ;
16) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0856 ;
17) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957 ;
18) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957 ;
19) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU2052 ;
20) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883 ;
21) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883 ;
22) PVCGOTACF, UDI-DI: 10195594816469(each), 50195594816467(case), Lot Number: NGKV3487 ;
23) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716 ;
24) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716 ;
25) PVX4TAMYC, UDI-DI: 10198956329379(each), 50198956329377(case), Lot Number: NGKU4716 ;
26) PV23HEVAE, UDI-DI: 10198956062160(each), 50198956062168(case), Lot Number: NGKT2391 ;
27) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ;
28) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ;
29) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ;
30) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ;
31) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: NGKU0129 ;
32) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: NGKU0129 |
| FEI Number |
3001236905
|
Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
|
| For Additional Information Contact | Cardinal Health Quality Systems
800-292-9332 |
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Manufacturer Reason
for Recall | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation. |
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FDA Determined
Cause 2 | Process change control |
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| Action | An URGENT: PRODUCT CORRECTION notification letter dated 7/29/26 was sent to customers.
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:
gmb-FieldCorrectiveAction@cardinalhealth.com
For component credit or replacement, please contact the following:
" Hospitals Cardinal Customer Service at 866.551.0533
" Distributors Distributor Management at 800.635.6021
" Federal Government facilities Government Customer Service at 800.444.1166
If you are a Distributor and have further distributed affected kits please notify your customers of this recall.
We sincerely apologize for any inconvenience this notice may have caused you and your staff.
Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332. |
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| Quantity in Commerce | 846 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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