The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0215-2015·Announced 2014-11-26

Soma Access Systems Recalls AxoTrack I Sterile Procedure Kits

Soma Access Systems is recalling 3,530 units of AxoTrack I Sterile Procedure Kits because the sterile packaging may fail before the expiration date.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where sterile packaging may fail, posing a risk of infection or harm to patients, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Soma Access Systems LLC is recalling 3,530 units of AxoTrack I Sterile Procedure Kits (18G). The recall involves specific product reference numbers and lot numbers with expiration dates ranging from February 28, 2014, to October 31, 2014. The kits are sterile procedure kits used with AxoTrack enabled Ultrasound Transducers for magnetic needle tracking.

The recall was initiated because there is a possibility that the sterile packaging may fail before the expiration date specified on the package. This potential failure could compromise the sterility of the contents.

The affected products were distributed nationwide in the United States, including states such as Alabama, Arizona, California, and others, as well as in Belgium, Hong Kong, India, Japan, Panama, and Singapore. Consumers and healthcare providers should stop using the affected kits and contact Soma Access Systems for further instructions.

The recalled product

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.
Manufacturer
Soma Access Systems LLC
Category
Medical Device — Surgical Kits
Hazard
Affected units
3,530

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • Product Ref#70956
  • Lot #62191-000
  • Expiration Date: 2/28/2014
  • Lot #62193-000
  • Lot #62360-000
  • 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
  • Lot # 62435-000
  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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