The Recall Desk
HighFDA (Devices)·Z-1854-2013·Announced 2013-08-14

Hospira Recalls Blood Sets Due to Potential Puncture of Blood Bags

Hospira Inc. is recalling 96 units of PLUM 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 a defect could compromise blood product integrity, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Hospira Inc. is recalling 96 units of PLUM BLOOD SETS (List No. 14210-28, Lot No. 053835H). These medical devices are 100 mL burettes designed for blood product administration. The affected units were 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 blood sets to puncture the outer wall of blood bags during the insertion of the pin into the bag. This defect could compromise the integrity of the blood product container.

Consumers and healthcare facilities should stop using the affected blood sets immediately. Product inquiries should be directed to Hospira Inc. in Lake Forest, IL.

The recalled product

Product
List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 600
Manufacturer
Hospira Inc.
Category
Medical Device — Blood Administration Sets
Hazard
Affected units
96

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: 14210-28
  • Lot Number: 053835H

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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