Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095,
FDA device recall Z-0552-2011 · posted 2010-12-08 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Action taken
- Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 124 units
- Distribution
- Nationwide Distribution in the states of CA, IL, IN, and UT.
- Date initiated
- 2010-10-25
- Date posted
- 2010-12-08
- Date terminated
- 2012-03-23
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERIT CUSTOM KIT (K913682) | Merit Medical Systems, Inc. | 1991-11-15 |