Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
FDA device recall Z-1779-2022 · posted 2022-09-23 · Terminated
Recall details
- Recalling firm
- SunMed Holdings, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CBT
- Quantity affected
- 53,560 units
- Distribution
- Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
- Date initiated
- 2022-09-08
- Date posted
- 2022-09-23
- Date terminated
- 2024-06-18
- Location
- Grand Rapids, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PISTON SYRINGE (K944941) | Martell Medical Products, Inc. | 1994-12-05 |