Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Recall
- Recall Number
- Z-0465-2022
- Event Number
- 89126
- Firm
- Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands
- FEI Number
- 3001450493
- Product Code
- GXZ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 8, 2021
- Terminated
- May 31, 2024
Description
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
The firm distributed an Urgent Medical Device Recall notice dated 12/07/2021 to customers in the United States via email on 12/08/2021. In this notice the firm identifies affected product as being recalled due to the high risk of the needle electrode and lead wire coming loose from the hub, resulting in potential medical intervention to remove the inserted needle electrode, including removal using forceps or incision. The recalling firm requested that customers notify any recipients of recalled product down the distribution chain by forwarding a copy of the notice, that the customer be aware that the firm will schedule a telephone call to initiate the replacement of affected product, and that only distributors return the provided Acknowledgement Form following the scheduled phone call to [email protected]. Customers are asked to ascertain the amount of affected product on hand to be returned with their lot numbers for the scheduled call. Customers with any questions are to contact the recalling firm at [email protected] or by phone at +31 43 608 48 48.
US Nationwide distribution in the states of California, Florida, and Ohio.
117,672 devices