Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
FDA device recall Z-0444-2016 · posted 2015-12-17 · Terminated
Recall details
- Recalling firm
- Myco Medical Supplies Inc
- Reason for recall
- Particulates: Complaints of rubber coring from the closure of injection vials.
- Action taken
- MYCO Medical sent an Advisory Notice dated November 6, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory, if any affected product found MYCO request that the customer return the product to MYCO Medical following the instructions provided on the Materials for Return Form. Customers with questions were instructed to call Customers Service at 919-460-2535/ customerservice&mycomedical.com or cal the Quality Department at 919-460-2535/ QA@mycomedical.com.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)
- Distribution
- Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
- Date initiated
- 2015-11-06
- Date posted
- 2015-12-17
- Date terminated
- 2017-05-03
- Location
- Cary, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES (K945225) | Myco Medical Supplies, Inc. | 1995-01-26 |