The Recall Desk
HighFDA (Devices)·Z-1328-2014·Announced 2014-04-09

Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports

Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to complaints of leakage of insufflation gas through the device.

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 is classified as FDA Class II, and the hazard involves a functional defect (gas leakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Teleflex Medical is recalling 55,521 units of 5/10 Weck Vista Universal Balloon Open Access Ports in standard, long, and short lengths. The recall is being conducted due to complaints of leakage of insufflation gas through the device.

The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam. Specific lot numbers are listed in the agency's recall record.

Healthcare facilities should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.

The recalled product

Product
5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No. 41
Manufacturer
Teleflex Medical
Category
Medical Device — Endoscopy Accessories
Hazard
Affected units
55,521

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)

  • Lots  Catalog No. 410944 - 01K1200601
  • 01K1200623
  • 01L1200355
  • 01L1200378
  • 01A1300203
  • 01D1300412
  • 01J1200241
  • 01K1200066
  • 01K1200622
  • Catalog No. 410944L - 01J1200219
  • 01K1200067
  • 01K1200600
  • 01L1200056
  • 01L1200354
  • 01A1300202
  • Catalog No. 410944S - 01L1200460
  • 01K1200619
  • 01L1200515
  • 01E1300137
  • Catalog No. 412944  01J1200241

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Teleflex Medical 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 · Teleflex Medical

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Same hazard · gas leakage

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