Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVAS

FDA device recall Z-0916-2025 · posted 2025-01-15 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

OJH

Quantity affected

512,786 total units

Distribution

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

Date initiated

2024-11-08

Date posted

2025-01-15

Location

Waukegan, IL