The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1625-2014·Announced 2014-05-28

Hospira Recalls Cystoscopy Sets Due to Potential Sterile Package Seal Defect

Hospira Inc. is recalling specific cystoscopy and irrigation 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a potential breach of the sterile barrier without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Hospira Inc. is recalling specific medical device sets, including the Cystoscopy/Irrigation Set (List No. 06544-01), Latex Free Extension Set (List No. 04693-01), Nonvented Y-Set for Transurethral Resection (List No. 06543-01), Large Bore Y-Irrigation Set (List No. 06599-01), and 4-Lea (List No. 15239-01). 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 distributed worldwide, including nationwide in the United States and in specific countries such as Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, and the United Arab Emirates. The recall covers 1,613,775 sets across multiple lot numbers.

Healthcare providers and facilities should stop using the affected products and contact Hospira Inc. for instructions on return or replacement. Patients who have received these products should consult their healthcare provider if they have concerns regarding the integrity of the sterile packaging.

The recalled product

Product
LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation
Manufacturer
Hospira Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,613,775

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. 6544-04-01 (6544-01)
  • Lot Numbers: 13107NS
  • 13108NS
  • 13171NS
  • 13172NS
  • 15141NS
  • 15142NS
  • 15143NS
  • 16113NS
  • 16114NS
  • 16115NS
  • 16116NS
  • 16174NS
  • 16175NS
  • 16176NS
  • 17134NS
  • 18112NS
  • 19130NS
  • 19131NS
  • 19132NS

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 →

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