Recall Z-3154-2024 ยท FMF Syringe, Piston
Cypress Medical Products LLC
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
| Date | Sep 16, 2024 (initiated Aug 6, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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 MMSQRCProductReviews@Mckesson.com. 3. If you have further dist |
| Quantity | 3 Boxes (25 per box, 75 total units) |
| Distribution | US Nationwide distribution in the states of CA, NV, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.