Agency classClass IOur severity:Severe FDA (Devices)·Z-1850-2013·Announced 2013-08-14

Hospira Recalls Secondary Blood Sets Due to Piercing Pin Defect

Hospira Inc. is recalling 672 units of secondary 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 672 units of List No. 14200-28 Secondary Blood Sets. These non-DEHP blood sets, manufactured in Costa Rica, are designed for blood product administration and feature a 200-micron filter and 36-inch length.

The recall was initiated because it was discovered that the piercing pin on certain units has the potential to puncture the outer wall of blood bags during insertion. The affected lot numbers are 022045H, 022055H, 030605H, and 201765H.

The affected products were distributed nationwide in the United States, in Puerto Rico, and internationally to Costa Rica. Consumers and healthcare providers should stop using these specific blood sets and contact Hospira Inc. for further instructions.

The recalled product

Product: List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 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…
Manufacturer: Hospira Inc.
Category: Medical Device — Blood Administration Sets
Hazard: puncture-injury
device-defect
Affected units: 672

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 Number: 14200-28
Lot Numbers: 022045H
022055H
030605H
201765H

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 →

Same manufacturer · Hospira Inc.

See all →

Critical
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
Moderate
Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
Low
Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
Severe
Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
High
Hospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16

Same hazard · puncture injury