Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1623-2014·Announced 2014-05-28

Hospira Recalls Latex-Free Extension Sets Due to Packaging Seal Defect

Hospira is recalling specific latex-free extension 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 hazard is a packaging defect that compromises sterility. No illnesses or injuries are reported in the source text, and the risk is theoretical rather than confirmed harm, fitting the Moderate criteria for low-risk contamination or precautionary recalls.

Plain-English summary

Hospira Inc. is recalling specific lots of Latex-Free Extension Sets (List No. 4693-01) used for bladder irrigation or urinary drainage. 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. This issue affects 42,292 sets distributed in the United States and several international locations.

The source text indicates that this packaging defect is associated with several related product lists, including the Nonvented Y-Set for Transurethral Resection, Cystoscopy / Irrigation Set, and Large Bore Y-Irrigation Set. The specific lot numbers for the recalled extension sets are 16119NS, 17186NS, 21134NS, and 25129NS.

Healthcare facilities and consumers should check their inventory for these specific list and lot numbers. If the products are found, they should be removed from use and returned to the supplier or Hospira Inc. for credit or replacement, as the compromised sterile barrier may pose a risk of contamination.

The recalled product

Product: LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage
Manufacturer: Hospira Inc.
Category: Medical Device — Urological Devices
Hazard: packaging-defect
sterility-compromise
Affected units: 42,292

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 (5)

List No. 4693-04-01 (4693-01)
Lot Numbers: 16119NS
17186NS
21134NS
25129NS

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 →

Same manufacturer · Hospira Inc.

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Same hazard · packaging defect