Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU D

FDA device recall Z-1811-2025 · posted 2025-05-31 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

Action taken

On April 22, 2025, the firm notified customers of the recall through letters titled Immediate Action Required Voluntary Medical Device Recall. Customers were instructed to identify and quarantine all affected product on hand. Customers are to submit a response form to the recalling firm. Upon receipt of the response firm, Medline will provide the customer with over-labels to place on affected inventory, which will include instructions for staff to remove and discard the affected component prior to using the kit. Distributors should notify downstream customers/accounts of this recall. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

OJH

Quantity affected

1,853 total

Distribution

US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.

Date initiated

2025-04-22

Date posted

2025-05-31

Location

Northfield, IL