FDA Recall Open, Classified

General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

Recall: Z-3154-2024 · Initiated August 6, 2024

Recall

Recall Number
Z-3154-2024
Event Number
95223
Firm
Cypress Medical Products LLC
FEI Number
1451040
Product Code
FMF
Status
Open, Classified
Root Cause
Process control
Initiated
August 6, 2024
Posted
September 16, 2024
Address
9954 Mayland Dr, Richmond, VA, 23233-1464

Description

General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

Reason

The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.

Action

An Urgent Product Recall Notification letter dated 8/6/24 was sent to customers. Actions to be Taken 1. Immediately quarantine and discontinue use of any product matching the affected items and lot numbers listed above. Affected items should be destroyed on location per appropriate local, state, and federal disposal requirements. 2. Please complete and return the enclosed response form (Attachment #1) as soon as possible, even if you do not have any product on hand or have already consumed the product. Return completed form to [email protected]. 3. If you have further distributed this product to end users, please notify them immediately of this urgent product recall and ask them to segregate and quarantine this product immediately. You are encouraged to include a copy of this notification letter in your communication with any of these end users. If you have questions regarding this notification, please contact McKesson directly by phone at (800) 688-8840 or email [email protected]. Representatives are available Monday Friday, 8:00 am 5:00 pm PST.

Distribution

US Nationwide distribution in the states of CA, NV, NY.

Quantity

3 Boxes (25 per box, 75 total units)