12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA device recall Z-2368-2008 · posted 2008-09-21 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Control Syringes may be non-sterile due to holes in the packaging.
- Action taken
- Urgent Product Recall letters dated 07/09/08, were faxed on 07/09/2008 to consignees/sales reps. The letter instructed consignees/sales reps to contact their customers by phone or visit to provide recall information and instructions. Customers were told to immediately discontinue use and to quarantine all affected products. A Product Retrieval Form was provided that was to be signed by the site representative. Contact Merit Medical at 1-801-208-4408 for assistance.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 100 units
- Distribution
- CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan.
- Date initiated
- 2008-07-09
- Date posted
- 2008-09-21
- Date terminated
- 2008-11-03
- Location
- South Jordan, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE CORONARY CONTROL SYRINGE 12CC (K875196) | Merit Medical Systems, Inc. | 1988-02-11 |