Recall Z-1779-2022 ยท CBT Arterial Blood Sampling Kit
SunMed Holdings, LLC
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
| Date | Sep 23, 2022 (initiated Sep 8, 2022) |
| Status | Terminated |
| Reason | The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle. |
| Root cause | Process control |
| Action | On September 8, 2022, the firm sent Urgent Medical Device Product Removal letters via email to affected customers. Customers were instructed to either return or destroy and discard affected product. If customers have further distributed the affected device, they should forward the notification to the receiving facility. Sun Med will provide new replacement product. If you have any questions regarding this field action, please call SunMed at 1-800-433-2797, or e-mail at productquality@sun-med.com. |
| Quantity | 53,560 units |
| Distribution | Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944941 | PISTON SYRINGE Martell Medical Products, Inc., Dec 5, 1994 |