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Recall Observatory FDA recall evidence

Device product

AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.

Z-0215-2015

March 24, 2014

Class II

Product summary

Firm
Soma Access Systems LLC
Event
Event 69619
Status
Terminated
Classification
Class II
Quantity
3530 units
Official record key
device-enforcement:Z-0215-2015

Official wording

Reason: There is a possibility the sterile packaging may fail before the expiration date specified on the package.

Code information: Product Ref#70956, Lot #62191-000, Expiration Date: 2/28/2014, Lot #62193-000, Expiration Date: 2/28/2014, Lot #62360-000, Expiration Date: 2/28/2014, Lot #62922-000, Expiration Date: 4/30/2014, Lot #63191-000 and Expiration Date: 10/31/2014 (24/case labeled for US); Product Ref#70957, Lot # 62188-000, Expiration Date: 2/28/2014, Lot # 62435-000, Expiration Date: 2/28/2014, Lot # 62489-000 Expiration Date: 3/31/2014 and Lot # 63191-000, Expiration Date: 10/31/2014 (5/case labeled for US); Product Ref#71489, Lot # 63191-000, Expiration Date: 10/31/2014 (24/case labeled for EU) and Product Ref#71489, Lot # 62489-000, Expiration Date: 3/31/2014, Lot # 62529-000, Expiration Date: 3/31/2014 and Lot # 63191-000 Expiration Date: 10/31/2014 (5/case labeled for EU).

Distribution pattern: Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a possibility the sterile packaging may fail before the expiration date specified on the package.