NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6

FDA device recall Z-0125-2018 · posted 2017-11-18 · Terminated

Recall details

Recalling firm

Halyard Health, Inc

Reason for recall

Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.

Action taken

Customers were notified via FedEx on 10/06/2017. Instructions included to evaluate and quarantine any affected product in current inventory. For their direct distributors, instructions were to complete and return the response form and also coordinate the return of any affected product. If further distributed, those end users and customers were instructed to destroy any affected product.

Root cause

Under Investigation by firm

Status

Terminated

Product code

BSY

Quantity affected

52,660 kits (2,633 cases) with 631,920 saline vials

Distribution

Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV

Date initiated

2017-10-06

Date posted

2017-11-18

Date terminated

2020-09-01

Location

Alpharetta, GA