The Recall Desk
HighFDA (Devices)·Z-1423-2018·Announced 2018-04-25

Carefusion Illinois Needle Aspiration Recall Due to Compromised Sterile Packaging

Carefusion 2200 Inc is recalling specific lots of Illinois needle aspiration devices because their sterile packaging integrity is potentially compromised.

What this means for you

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 risk-of-harm product (compromised sterile packaging) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Carefusion 2200 Inc is recalling specific lots of ILLINOIS (TJ) NEEDLE ASPIRATION devices, available in 15GA and 18GA sizes. The recall affects 13,010 units of the 15GA product and 2,116 units of the 18GA product. These sterile medical devices were distributed nationwide and in several international markets, including Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, the Netherlands, New Zealand, the Philippines, Singapore, South Africa, Taiwan, Thailand, the United Arab Emirates, and Vietnam.

The recall was initiated because the integrity of the sterile packaging is potentially compromised. This defect may affect the sterility of the devices, which is critical for their safe use in medical procedures.

Healthcare facilities and consumers who possess these specific product codes and lot numbers should stop using the devices and contact Carefusion 2200 Inc for instructions on return or replacement. The affected product codes are TIN3015 and TIN3018, with specific lot numbers listed in the official recall notice.

The recalled product

Product
ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Needle Aspiration
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 (14)

  • Product Code: a.) TIN3015/ LOT 0000836578
  • 0000841213
  • 0000841215
  • 0000842719
  • 0000842721
  • 0000845423
  • 0000848061
  • 0000849715
  • 0000850938
  • 0000852076
  • 0000854859
  • Product Code: b.) TIN3018/ LOT 0000836574
  • 0000841212
  • 0000852078

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Carefusion 2200 Inc

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Same hazard · sterility compromise

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