Medical device manufacturer, Johnson & Johnson International, has issued a medical device safety alert concerning Temporary Cardiac Pacing Wire [Product codes.: FEP13E and FEP15E].
The manufacturer is recalling multiple lots of affected product due to the potential presence of silicone on the blue coating of the stainless steel device.
As a precautionary measure, the manufacturer is requesting that users immediately discontinue use of Temporary Cardiac Pacing Wire from the following table of product codes and lot numbers:
| Lot number | Item Code |
|---|---|
| DK2GGSP0 | FEP15E |
| DK2DZZP0 | FEP15E |
| DK2DPDP0 | FEP15E |
| DK2DDWP0 | FEP15E |
| DK2CWMP0 | FEP13E |
| DK2CMWP0 | FEP15E |
| DK2CGJP0 | FEP15E |
| DK2CCGP0 | FEP13E |
| DK2BTLP0 | FEP13E |
| DK2BDDP0 | FEP13E |
| DJ2DPGP0 | FEP15E |
According to the local supplier, Johnson & Johnson (HK) Limited, the affected devices were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 19 October 2012