Recall Z-0467-2019
Stryker Sustainability Solutions · initiated August 23, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Codes / lots: Item Number Serial Number D134903 2519054 D134903 2534027 Note: Item # D134909 is not approved for reprocessing by Stryker s Sustainability Solutions Division. Therefore, SSS does not create or possess D134909 labeling. SSS did not receive labeling from the manufacturer.
Reason for recall
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
FDA-determined cause: Under Investigation by firm
Action taken
On 10/30/2018 an Urgent Medical Device Recall notice was hand-delivered by a sales representative to the customer. The customer was notified that the affected devices had already been returned via the normal collections process. If affected devices were forwarded to additional facilities, the customer was asked to communicate this recall to them and to provide them with the recall effectiveness check form. Customers were asked to complete and return the recall effectiveness check form.
Details
- Recall number
- Z-0467-2019
- Initiated
- August 23, 2018
- Terminated
- February 4, 2021
- Product code
- NLH – Catheter, Recording, Electrode, Reprocessed
- Quantity
- 2
- Distribution
- US: KS OUS: None
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ