The Recall Desk
HighFDA (Devices)·Z-1626-2014·Announced 2014-05-28

Hospira Recalls Large Bore Y-Irrigation Sets Due to Packaging Seal Defect

Hospira is recalling specific lots of Large Bore Y-Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

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 medical device where a packaging defect compromises the sterile barrier, creating a risk of infection or harm. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Hospira Inc. is recalling 167,574 sets of Large Bore Y-Irrigation Sets (List No. 6599-01) due to a defect in the packaging. The Tyvek cover on these devices may not be completely sealed to the rest of the package, which allows for openings at the edge of the sterile package. This defect affects the integrity of the sterile barrier for the irrigation sets.

The affected products are distributed worldwide, including nationwide in the United States and in several international countries such as Canada, Barbados, and Costa Rica. The recall includes specific lot numbers ranging from 12145NS to 34143NS. The source text also notes that similar packaging defects have been identified in other Hospira irrigation and extension sets, including the Latex Free Extension Set and Nonvented Y-Set for Transurethral Resection.

Healthcare facilities and consumers should check their inventory for the specific list number and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Hospira Inc. according to the recall instructions.

The recalled product

Product
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
Manufacturer
Hospira Inc.
Category
Medical Device — Irrigation Sets
Hazard
Affected units
167,574

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. 6599-04-01 (6599-01)
  • Lot Numbers:12145NS
  • 12146NS
  • 16120NS
  • 17130NS
  • 18113NS
  • 19134NS
  • 20196NS
  • 21132NS
  • 24120NS
  • 25134NS
  • 25211NS
  • 27112NS
  • 28273NS
  • 28274NS
  • 29098NS
  • 31040NS
  • 32296NS
  • 33142NS
  • 34143NS

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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