Hospira Inc.: 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.

Agency Publication Date: August 5, 2013

Affected Products

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 Administration

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

Lot Numbers:

Numbers

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

List Number: 14203-28; Lot Numbers: 030895H, 961465H

Lot Numbers:

Numbers

Product: List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 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

List Number: 14206-28; Lot Numbers: 020695H, 100865H

Lot Numbers:

Numbers

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

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

Lot Numbers:

Number

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 60045 USA Hospira Blood sets are designed for Blood Product Administration

List Number: 14210-28; Lot Number: 053835H

Lot Numbers:

Number

Product: List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 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

List Number: 14211-28; Lot Numbers: 052945H, 211855H

Lot Numbers:

Numbers

Product: List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 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

List Number: 14212-28; Lot Numbers: 030575H, 081425H, 090515H, 100905H, 100915H, 102255H, 102265H, 122515H, 122525H, 143405H, 143415H, 152655H, 152665H, 152675H, 161375H, 161385H, 161395H, 170955H, 172025H, 172035H, 172045H, 241805H, 250845H, 251735H, 251745H, 962235H

Lot Numbers:

Numbers

Product: List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 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

List Number: 14217-28; Lot Number: 962255H

Lot Numbers:

Number

Product: List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 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

List Number: 14219-28; Lot Number: 962245H

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65689

Status: Resolved

Manufacturer: Hospira Inc.

Manufactured In: United States

Units Affected: 9 products (672 units; 1,152 units; 1,976 units; 240 units; 96 units; 288 units; 692,742 units; 1,104 units; 3,600 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

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

Lot Numbers:

Numbers

List Number: 14203-28; Lot Numbers: 030895H, 961465H

Lot Numbers:

Numbers

List Number: 14206-28; Lot Numbers: 020695H, 100865H

Lot Numbers:

Numbers

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

Lot Numbers:

Number

List Number: 14210-28; Lot Number: 053835H

Lot Numbers:

Number

List Number: 14211-28; Lot Numbers: 052945H, 211855H

Lot Numbers:

Numbers

Lot Numbers:

Numbers

List Number: 14217-28; Lot Number: 962255H

Lot Numbers:

Number

List Number: 14219-28; Lot Number: 962245H

Lot Numbers:

Number