Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1" R
FDA device recall Z-1126-2012 · posted 2012-02-29 · Terminated
Recall details
- Recalling firm
- Medisystems Corp
- Reason for recall
- Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle
- Action taken
- Medisystems Corporation issued notice of recall to distributors on January 31, 2012. Distributors to notify affected end users by letter. Each letter was accompanied by a response form and instructions on how to return the response form. End users were given the option of returning involved product for credit or replacement. Contact Medisystems Quality Assurance Manager at (978) 332-5973 for information.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FIE
- Quantity affected
- 20,750 units (83 cases)
- Distribution
- USA (nationwide) including the states of AZ, CA, CO, OR, NV, NY, TN, and WA.
- Date initiated
- 2012-01-31
- Date posted
- 2012-02-29
- Date terminated
- 2012-09-12
- Location
- Lawrence, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDISYSTEMS HEMODIALYSIS FISTULA SET (K910734) | Medisystems Corp. | 1991-06-20 |