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Recall Observatory FDA recall evidence

Device product

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

Z-0117-2018

October 06, 2017

Class II

Product summary

Firm
Halyard Health, Inc
Event
Event 78391
Status
Terminated
Classification
Class II
Quantity
52,660 kits (2,633 cases) with 631,920 saline vials
Official record key
device-enforcement:Z-0117-2018

Official wording

Reason: 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.

Code information: Product Code 2216 with Lot AB6032U03; Product Code 22056 with Lot AB6032U12; Product Code 220569 with Lot AB6207U11

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.