Device Recall Peripherally Inserted Central Catheters (PICC) 의 리콜

Recall

75322

Class 2

Z-0708-2017

2016-08-29

Terminated

United States

2018-06-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150100

Medline industries, inc. supplies navilyst with sterile package gloves included in the tandem packing of the maximal barrier nursing kits. medline has determined that specific lots of the gloves supplied to navilyst contain an incorrect expiration date. navilyst has confirmed that medlines affected sterile gloves (medline part number msg1075/msg3075) have been included in a limited number of kits.

Navilyst sent an Urgent Voluntary Medical Device Recall notices, reply forms and a copy of Medline's Recall Notice to the their customers. The letter identified the product, the problem, and the action to be taken by the customer. Navilyst Medical, Inc. (an AngioDynamics Company), the manufacturer of the Xcela" PICC w/PASV, the BioFlo PICC w/ Endexo, and the BioFlo PICC w/ Endexo and PASV is conducting a medical device recall based on information received from Medline. Medline has determined that the sterile gloves listed in their Recall Notification dated August 3, 2016 may contain an incorrect expiration date. Actions to be taken: - Customers should immediately remove the affected product from inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). - Segregate this product in a secure location for return to Navilyst Medical. - Immediately forward a copy of this recall notification to all sites to which customers may have further distributed affected product. Customers should also promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) via email to recall@angiodynamics.com. Customers with questions can call 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time). For questions regarding this recall 518-792-4112.