Z-0914-2025Class II

Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY...

Name: Z-0914-2025 Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY...
Creator: Cardinal Health 200, LLC
Published: 2024-11-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-11-08 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY... on 2024-11-08. FDA classified it as Class II and gives the reason as "Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0914-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-08
Posted: 2025-01-15
Recalling firm: Medtronic, Inc.
Product: Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH8 6 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH9 7 ) KIT, FETAL SURGERY , Catalog Number PB11FSCHR
Product code: OHD Gynecological Laparoscopic Kit
Reason for recall: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Root cause tag: manufacturing process
FDA 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 [email protected], 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 in commerce: 512,786 total units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Product codes and lots: Catalog Number PB11FSC10, UDI/DI 10197106452042 (EA)50197106452040 (CS), Lot Number 6928760 ; Catalog Number PB11FSCH5, UDI/DI 10195594665951 (EA)50195594665959 (CS), Lot Number 5891312 ; Catalog Number PB11FSCH6, UDI/DI 10195594760984 (EA)50195594760982 (CS), Lot Number 6022131 ; Catalog Number PB11FSCH7, UDI/DI 10195594788704 (EA)50195594788702 (CS), Lot Number 6025788 ; Catalog Number PB11FSCH8, UDI/DI 10197106000229 (EA)50197106000227 (CS), Lot Number J6278R ; Catalog Number PB11FSCH9, UDI/DI 10197106404751 (EA)50197106404759 (CS), Lot Number 6788562 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 7280109 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 6487904 ;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0914-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0908-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15
Z-0909-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15
Z-0910-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15
Z-0911-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15
Z-0912-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15
Z-0913-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15
Z-0914-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15
Z-0915-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15
Z-0916-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15
Z-0917-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15

Product code OHD

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)