Device Recall Perifix FX Epidural Anesthesia Tray 의 리콜

Recall

78878

Class 2

Z-0571-2018

2017-06-21

Terminated

United States

2018-04-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160788

B. braun medical inc. (bbmi) initiated this recall of various bbmi convenience kits containing the 22ga 1-1/2in safetyglide needle due to the presence of loose polypropylene foreign matter was above release specification. this foreign matter has been identified as a product hub material which has been tested for biocompatibility per iso 10993 during the product development process.

The firm, BD, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 6/12/2017 to its customers/kit packers. B.Braun Medical Inc. (BBMI), sent a "VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated 6/23/2017 to all BBMI customers in receipt of suspect product. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. The letters described the product, problem and actions to be taken. The customers were instructed to review the device notification in its entirety and inform all users of the recall; determine your inventory of the affected product-Do not destroy any affected product; complete and return the "Product Removal Acknowledgement" form to B.Braun Medical Inc. Quality Assurance department via fax to 610-849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraun.com within two 2 weeks of receipt, even if the total inventory in your possession is zero 0; and if you have any full cases, partial cases or unused individual pieces a BBMI Customer Support Representative will contact you to provide instructions for handling affected product and arrange for return. Should you have any questions or concerns regarding the recall, please contact our Customer Support Department at 800-227-2862.