ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION 의 리콜

Recall

58658

Class 2

Z-2420-2011

2011-04-29

2011-06-07

Terminated

United States

2014-04-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99797

2 models model 1: orthopat devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled model 2: orthopat equipped with a spill collection drainage system updated with revised instructions for use and quick reference guide addendum.

The firm, Haemonetics, sent an "Urgent Field Recall" letter dated April 29, 2011 to all customers. The letter describes the product, problem and actions to be taken. This recall covers the 2 models. Model 1: OrthoPAT devices without drain ports (Serial numbers 00001 through 02279-T). All OrthoPAT devices without drain ports worldwide, will be removed from distribution and scrapped. Model 2: OrthoPAT devices with drain ports (serial numbers beginning with 02280-T and higher). All OrthoPAT devices with drain ports will remain in clinical use and will receive updated labeling. The customers were instructed to follow the enclosed directions to confirm their possession of any units of this model and arrange for their return to Stericycle; immediately cease use of devices not equipped with a spill collection drainage system ( to determine whether their OrthoPAT device is equipped with the spill collection drainage system, please refer to the attached illustrations/instructions); complete and return the IMPORTANT-CUSTOMER CONFIRMATION sheet via fax to: Stericycle at 1-866-792-5450, and RETURN the OrthoPAT devices NOT equipped with spill collection drainage system (for instructions on how to arrange return of OrthoPAT Devices, call a Stericycle Representative at 1-866-918-8736). A Haemonetics representative will be in contact with the customers facility within 14 working days to assist with the recall actions. The firm, Haemonetics, will update the OrthoPAT labeling. The labeling will have specific instructions to permanently deploy the centrifuge spill collection bag at all times. Device cleaning instructions in the event of a blood spill are also clarified and include specific instructions to unplug the device from the AC outlet in the event of a fluid spill on the device. If a device does experience a fluid spill, new instructions direct the user to return the device to Haemonetics for evaluation and repair. Operator Manuals will be replaced with a new revisi