Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;

Recall number

Z-0909-2025

Recalling firm

Cardinal Health 200, LLC

Product

Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;

Status

Open, Classified

Initiated

2024-11-08

Posted

2025-01-15

Terminated

not on file

Reason

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Root cause

Nonconforming Material/Component

Action

An URGENT: PRODUCT RECALL notification letter dated 11/8/24 was sent to customers. If you locate affected product within your facility, please complete the following: 1. REVIEW your inventory immediately stop using the affected product code and lots attached. 2. COMMUNICATE with all personnel who utilize the Presource Kits containing CODMAN Patties & Strips component produced by Integra LifeSciences. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product or to whom you plan to send the product about this medical device product correction and share a copy of this notice. 1. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMBFieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not. For Presource kit 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. In the event you have experienced quality problems or adverse events related to the products listed above, please utilize the contacts above to report the event. 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.

Quantity

512,786 total units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Lot, serial or model codes

Catalog Number SBAOCTEHH1, UDI/DI 10195594722685 (EA)50195594722683 (CS), Lot Number 21J2883 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18E1332 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18H2278 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18J2582 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18M3535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18M3535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19A0124 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19E1525 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19K3308 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number N/A ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19K3308 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19C0888 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18H2278 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19C0888 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19A0124 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19B0560 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SEN15SERM5, UDI/DI 10195594423469 (EA)50195594423467 (CS), Lot Number 5533336 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J3987C ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J43U74 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J46A98 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J46C04 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J72P53 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J8393W ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J6050H ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J86T82 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 5140356 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 5891304 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 6264567 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 6928759 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7163104 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7331342 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7332908 ;

510(k) numbers

not on file

PMA numbers

not on file

Product code

NWU

Firm FEI

3001236905

Firm city

Waukegan

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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