The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1851-2013·Announced 2013-08-14

Hospira Blood Sets Recalled Due to Potential Bag Puncture Risk

Hospira is recalling 1,152 blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag."

Plain-English summary

Hospira Inc. is recalling 1,152 units of List No. 14203-28 Blood Sets. These products are designed for blood product administration and feature a 200-micron filter and non-DEHP components. The affected units were manufactured in Costa Rica and distributed nationwide in the United States, 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 blood sets to puncture the outer wall of blood bags during insertion of the pin into the bag. This defect could compromise the integrity of the blood product container.

The affected lot numbers are 030895H and 961465H. Consumers and healthcare providers should stop using these specific blood sets and contact Hospira Inc. for further instructions or replacement.

The recalled product

Product
List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 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
1,152

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 (3)

  • List Number: 14203-28
  • Lot Numbers: 030895H
  • 961465H

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 →

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