General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Numbe

FDA device recall Z-3154-2024 · posted 2024-09-16 · Open, Classified

Recall details

Recalling firm

Cypress Medical Products LLC

Reason for recall

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 taken

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 MMSQRCProductReviews@Mckesson.com. 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 MMSQRCProductReviews@Mckesson.com. Representatives are available Monday Friday, 8:00 am 5:00 pm PST.

Root cause

Process control

Status

Open, Classified

Product code

FMF

Quantity affected

3 Boxes (25 per box, 75 total units)

Distribution

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

Date initiated

2024-08-06

Date posted

2024-09-16

Location

Richmond, VA