Terminated

Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.

FDA Recall Z-0117-2018 · Posted 2017-11-18

Recalling FirmHalyard Health, Inc

Recall StatusTerminated

Product CodeBSY

Date Initiated2017-10-06

Date Terminated2020-09-01

Product Quantity52,660 kits (2,633 cases) with 631,920 saline vials

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.