PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x 48'' and 6''
FDA device recall Z-1074-03 · posted 2003-08-01 · Terminated
Recall details
- Recalling firm
- Rx Textiles Inc
- Reason for recall
- Product may not be sterile.
- Action taken
- Distributor was notified via email on 6/11/2003 and advised to quarantine the product. A follow up letter was sent via certified mail to the distributor and to the contract packer on 6/18/2003 with a questionnaire and a self addressed stamped envelope to verify effectiveness.
- Root cause
- Other
- Status
- Terminated
- Product code
- :
- Quantity affected
- 141 cases 25pk/Cs
- Distribution
- Product was shipped to one distribution center in CA who shipped product to consignees located in CA and NV.
- Date initiated
- 2003-06-11
- Date posted
- 2003-08-01
- Date terminated
- 2003-12-16
- Location
- Monroe, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RX TEXTILES STERILE STOCKINETTE (K960803) | Rx Textiles, Inc. | 1996-07-12 |