Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, a

FDA device recall Z-0287-2024 · posted 2023-11-09 · Open, Classified

Recall details

Recalling firm

Stryker Corporation

Reason for recall

Expired product distributed

Action taken

On 09/27/2023, Stryker issued a "Urgent Medical Device Recall Notification" to affected consignees via mail. Stryker ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your accounts. Response is required by November 30, 2023. 3. If affected product is found, quarantine and discontinue use of the recalled devices. 4. Please complete the response form on Appendix A of this notice and return devices back to Stryker Endoscopy. a. Please call Customer Service at 1-866-596-2022 or email endocustomersupport@stryker.com to arrange for product return. 5. If no product is found, complete acknowledgement form and return it back to Stryker.

Root cause

Process control

Status

Open, Classified

Product code

KDD

Quantity affected

19 kits

Distribution

US: NH, TX, NY, NJ, OH, MN OUS: None

Date initiated

2023-09-13

Date posted

2023-11-09

Location

San Jose, CA