The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1624-2014·Announced 2014-05-28

Hospira Recalls T-U-R Y-Sets Due to Potential Sterile Package Seal Defect

Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

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 a packaging defect could compromise sterility, posing a risk of infection (harm) to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Hospira Inc. is recalling specific lots of T-U-R Y-Sets (List No. 6543-01) used for transurethral resection procedures. The recall is due to a defect where the Tyvek cover may not be completely sealed to the rest of the package, allowing openings at the edge of the sterile package.

The affected products are single-use, latex-free, nonvented sets measuring 96 inches (244 cm) intended for flexible irrigation container systems. The recall covers 1,109,321 sets in the United States and 15,113 sets distributed in foreign countries. Distribution in the US was nationwide, including the District of Columbia and Puerto Rico, while foreign distribution included Barbados, Canada, Costa Rica, the Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, and the United Arab Emirates.

The source text notes that this sealing issue affects several related product lines, including Latex Free Extension Sets, Cystoscopy / Irrigation Sets, and Large Bore Y-Irrigation Sets. Users should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units.

The recalled product

Product
LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
Manufacturer
Hospira Inc.
Category
Medical Device — Surgical Instrument
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)

  • List No. 6543-04-01 (6543-01)
  • Lot Numbers: 13106NS
  • 13170NS
  • 13251NS
  • 14261NS
  • 14262NS
  • 15139NS
  • 16117NS
  • 17131NS
  • 17132NS
  • 17184NS
  • 18110NS
  • 18111NS
  • 18182NS
  • 19133NS
  • 20122NS
  • 20123NS
  • 20124NS
  • 20205NS
  • 22146NS

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 compromise

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