openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 9
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
List Number: 14200-28; Lot Numbers: 022045H, 022055H, 030605H, 201765H
Distribution pattern
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
device · product 2 of 9
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
List Number: 14203-28; Lot Numbers: 030895H, 961465H
Distribution pattern
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
device · product 3 of 9
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
List Number: 14206-28; Lot Numbers: 020695H, 100865H
Distribution pattern
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
device · product 4 of 9
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
List Number: 14207-28; Lot Number: 962295H
Distribution pattern
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
device · product 5 of 9
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
List Number: 14210-28; Lot Number: 053835H
Distribution pattern
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
device · product 6 of 9
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
List Number: 14211-28; Lot Numbers: 052945H, 211855H
Distribution pattern
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
device · product 7 of 9
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
device · product 8 of 9
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
List Number: 14217-28; Lot Number: 962255H
Distribution pattern
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
device · product 9 of 9
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
List Number: 14219-28; Lot Number: 962245H
Distribution pattern
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
