The Recall Desk
HighFDA (Devices)·Z-1627-2014·Announced 2014-05-28

Hospira Recalls Latex-Free 4-Lead T-U-R Irrigation Sets Due to Sealing Defect

Hospira Inc. is recalling 29,380 Latex-Free 4-Lead T-U-R Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising sterility.

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. The hazard involves a potential breach of sterility in a medical device used for invasive procedures, which poses a risk of harm (infection) even though specific injury reports are not detailed in the provided text.

Plain-English summary

Hospira Inc. is recalling 29,380 units of the Latex-Free 4-Lead T-U-R Irrigation Set (List No. 15239-01). The recall involves specific lot numbers: 13259NS, 17185NS, 18181NS, 23102NS, 27108NS, 28275NS, 29093NS, and 31041NS. These single-use sets are designed for transurethral resection procedures and are compatible with flexible irrigation container systems.

The recall was initiated because the Tyvek cover on the sterile package may not be completely sealed to the rest of the package. This defect allows for openings at the edge of the sterile package, which could compromise the sterility of the device. The source text notes that this issue affects several related Hospira irrigation and extension sets, including List Nos. 04693-01, 06543-01, 06544-01, and 06599-01.

The affected products were distributed worldwide, including nationwide in the United States (all 50 states, District of Columbia, and Puerto Rico) and in Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, and the United Arab Emirates. Healthcare facilities and consumers should stop using these specific lots and contact Hospira Inc. for instructions on return or replacement.

The recalled product

Product
LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures
Manufacturer
Hospira Inc.
Category
Medical Device — Surgical Irrigation
Hazard
Affected units
29,380

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 (9)

  • List No. 15239-04-01 (15239-01)
  • Lot Numbers: 13259NS
  • 17185NS
  • 18181NS
  • 23102NS
  • 27108NS
  • 28275NS
  • 29093NS
  • 31041NS

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Hospira 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 5 products in this recall →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · sterility breach

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