The Recall Desk
HighFDA (Devices)·Z-1853-2013·Announced 2013-08-14

Hospira Blood Sets Recalled Due to Potential Bag Puncture Risk

Hospira is recalling 240 blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

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 risk-of-harm product (medical device) where the defect could compromise the integrity of blood bags, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical or unreported harm.

Plain-English summary

Hospira Inc. is recalling 240 units of Blood Sets (List No. 14207-28; Lot Number: 962295H). These medical devices are designed for blood product administration and feature a 200-micron filter and non-DEHP components. The products were manufactured in Costa Rica and distributed nationwide in the United States, in Puerto Rico, and internationally to Costa Rica.

The recall was initiated because it was discovered that there is a potential for the piercing pin on certain units to puncture the outer wall of blood bags during the insertion of the pin. This defect could compromise the integrity of the blood bag during use.

The source text does not specify specific instructions for consumers or healthcare providers regarding the immediate handling of these units, nor does it report any specific injuries or illnesses associated with this defect. Users should refer to official FDA or manufacturer communications for specific disposal or return instructions.

The recalled product

Product
List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Manufacturer
Hospira Inc.
Category
Medical Device — Blood Administration Sets
Hazard
Affected units
240

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 (2)

  • List Number: 14207-28
  • Lot Number: 962295H

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · puncture risk

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