The Recall Desk
SevereFDA (Drugs)·D-0178-2017·Announced 2016-12-14

North American Rescue Recalls Advance Trauma Kits Due to Sterility Concerns

North American Rescue LLC is recalling Advance Trauma Kits because the manufacturer has concerns regarding the sterility of the eye wash irrigating solution.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The hazard involves a lack of assurance of sterility in a medical product, which poses a risk of serious temporary or medically reversible health consequences.

Plain-English summary

North American Rescue LLC is recalling specific lots of the Advance Trauma Kit. The recall is due to concerns raised by the manufacturer regarding the sterility of the eye wash irrigating solution contained within the kits.

The affected products are distributed nationwide as well as in Australia and Switzerland. Specific part numbers and lot numbers are listed in the recall documentation, including part numbers 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, and 85-0741.

Consumers should check their Advance Trauma Kits against the specific part and lot numbers provided in the official recall notice. If the product matches the recalled lots, consumers should stop using the eye wash solution and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
Manufacturer
North American Rescue LLC.
Category
Medical Device — Trauma Kits
Hazard

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 (20)

  • Kit Part # 85-0742 Kit Lot # 85-0742071816
  • Kit Part # 85-0748 Kit Lot # 85-0746061016
  • Kit Part # 85-0745 - Kit Lot # 85-0745042516
  • Kit Part # 85-0639 - Kit Lot # 85-0639080516
  • 85-0639060116
  • 85-0639061016
  • 85-0639071416
  • 85-0639072116
  • 85-0639050316
  • 85-0639050416
  • 85-0639051316
  • 85-0639082216
  • 85-0639090116
  • 85-0639090716
  • 85-0639080116
  • 85-0639091316
  • Kit Part # 85-0744 - Kit Lot # 85-0744072516
  • 85-0744060916
  • 85-0744052516
  • Kit Part # 85-0741- Kit Lot # 85-0741071416

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by North American Rescue LLC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · North American Rescue LLC.

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Same hazard · sterility

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