Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Need
FDA device recall Z-0714-2013 · posted 2013-01-24 · Terminated
Recall details
- Recalling firm
- Medisystems a NX Stage Company
- Reason for recall
- A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
- Action taken
- Medisystems sent a notification letter dated December 20, 2012 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to immediately open and inspect inventory for the affected products. Results of the inspection are to be provided to Medisystems and the product is to be returned to Medisystems. For questions call (978) 332-5973.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FIE
- Quantity affected
- 26 casesx 250 needles (6500needles)
- Distribution
- US Nationwide Distribution in the states of NY, PA and TN.
- Date initiated
- 2012-12-20
- Date posted
- 2013-01-24
- Date terminated
- 2013-10-10
- Location
- Lawrence, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDISYSTEMS BUTTONHOLE NEEDLE SETS (K990803) | Medisystems Corp. | 2000-01-06 |