Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS E
FDA device recall Z-1038-2012 · posted 2012-02-15 · Terminated
Recall details
- Recalling firm
- European Custom Manufacturing B.V.
- Reason for recall
- The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality.
- Action taken
- ECM sent an "ECMbv RECALL OF MCE TEMPORARY PACING WIRES" letter dated May 2, 2011 to all affected customers. Customers were also informed of a potential problem via e-mail and/or phone between April 18 and 21, 2011. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to place the affected product on hold and to return the product to the firm. For questions on this matter, contact ECM or MCE Customer Service at 1-877-886-1985.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LDF
- Quantity affected
- 2,120 individual units (106 boxes)
- Distribution
- Nationwide Distribution-including the states of AL, AR, CA, FL, GA, KY, NC, NV, NY, TX, VA, and WI.
- Date initiated
- 2011-04-18
- Date posted
- 2012-02-15
- Date terminated
- 2012-02-15
- Location
- Gemert, Netherlands
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE (K033858) | European Custom Manufacturing BV | 2004-07-12 |