Device Recall BD 의 리콜

Recall

75802

Class 2

Z-0740-2017

2016-11-07

2016-12-12

Terminated

United States

2017-09-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151303

Bd is conducting a voluntary product recall of the bd spinal anesthesia tray, cat (ref) 405671, lot b01k089d since a very low number of trays are incorrectly labeled as bd single shot epidural tray, cat (ref) 406069.

BD sent an Urgent Product Recall letter dated November 7, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately review their inventory for the affected product. Return the affected products with the Business Response Card form following the instruction on the enclosed packing instruction. The completed form should be faxed to 1-866-240-5212 or email the completed form to bd6549@stericycle.com. Customers with questions were instructed to call 1-866-792-5451. For questions regarding this recall call 866-792-5451.